{ "generatedAt": "2026-06-19T00:40:21.012Z", "source": "DrugsMonitor recall catalog", "recordCount": 50, "records": [ { "id": "cceebe82-ee82-4a03-a048-bd387e98b76b", "drugName": "24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/cceebe82-ee82-4a03-a048-bd387e98b76b" }, { "id": "6da95bbb-95c9-4afc-a912-050bb6ac31a3", "drugName": "H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/6da95bbb-95c9-4afc-a912-050bb6ac31a3" }, { "id": "d8f0bc8a-0830-4067-811a-82537278400e", "drugName": "Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/d8f0bc8a-0830-4067-811a-82537278400e" }, { "id": "75bf0918-cd44-4233-ba4e-88b34f2381e7", "drugName": "HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/75bf0918-cd44-4233-ba4e-88b34f2381e7" }, { "id": "a46af6f6-335a-4527-be91-8527f1a45e8d", "drugName": "Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.", "manufacturer": "Spectra Medical Devices, Llc", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Lack of Assurance of Sterility", "url": "https://drugsmonitor.com/recall/a46af6f6-335a-4527-be91-8527f1a45e8d" }, { "id": "277e8a5b-a36e-4df3-9291-7218a80d7e2e", "drugName": "HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.", "manufacturer": "Guardian Drug Co. 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Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/70ff6e85-8b29-4cc0-befc-9130256c6a15" }, { "id": "252002d1-8364-4705-b2de-86e34e349ccf", "drugName": "Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02", "manufacturer": "Eugia US LLC", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan", "url": "https://drugsmonitor.com/recall/252002d1-8364-4705-b2de-86e34e349ccf" }, { "id": "baab61ce-098a-4320-aa5c-7d3e6dffbd2e", "drugName": "TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/baab61ce-098a-4320-aa5c-7d3e6dffbd2e" }, { "id": "7994984e-eacd-410f-8b87-5744d9fdf95b", "drugName": "GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/7994984e-eacd-410f-8b87-5744d9fdf95b" }, { "id": "2ed800e7-1976-4828-8bf3-af4f61c3610e", "drugName": "HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/2ed800e7-1976-4828-8bf3-af4f61c3610e" }, { "id": "dd655f08-ec86-4742-ab69-0412e9eabe9c", "drugName": "DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/dd655f08-ec86-4742-ab69-0412e9eabe9c" }, { "id": "dda02d41-2596-4aac-91a8-b8ca8b64b6aa", "drugName": "CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/dda02d41-2596-4aac-91a8-b8ca8b64b6aa" }, { "id": "2e4f1af5-b4e8-4565-8715-7aa74d4cd4b3", "drugName": "EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/2e4f1af5-b4e8-4565-8715-7aa74d4cd4b3" }, { "id": "dbe95da5-9848-4e85-a30a-5d32fe3a1f02", "drugName": "GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/dbe95da5-9848-4e85-a30a-5d32fe3a1f02" }, { "id": "dcab59a4-5c7e-424d-a69b-3218b138da53", "drugName": "EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/dcab59a4-5c7e-424d-a69b-3218b138da53" }, { "id": "a85300d4-0ea0-458b-8283-463ba9f7cec0", "drugName": "Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV", "manufacturer": "SUN PHARMACEUTICAL INDUSTRIES INC", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona", "url": "https://drugsmonitor.com/recall/a85300d4-0ea0-458b-8283-463ba9f7cec0" }, { "id": "464defa2-554f-43ec-bf34-431d3edd4f02", "drugName": "Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/464defa2-554f-43ec-bf34-431d3edd4f02" }, { "id": "f3233645-1482-4215-8921-32ae125e752c", "drugName": "Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/f3233645-1482-4215-8921-32ae125e752c" }, { "id": "0dc3e5a7-c5be-48c2-a33a-b5f005b5645e", "drugName": "Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 6", "manufacturer": "Ascend Laboratories, LLC", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications", "url": "https://drugsmonitor.com/recall/0dc3e5a7-c5be-48c2-a33a-b5f005b5645e" }, { "id": "30e4cdf8-1eed-41ca-b726-08ae580fd15b", "drugName": "Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.", "manufacturer": "Asclemed USA Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.", "url": "https://drugsmonitor.com/recall/30e4cdf8-1eed-41ca-b726-08ae580fd15b" }, { "id": "e9fe3a61-40ba-4376-a976-3b5660d24e32", "drugName": "TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/e9fe3a61-40ba-4376-a976-3b5660d24e32" }, { "id": "7fa0bc19-ba89-480b-979d-e5af7d15e972", "drugName": "FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/7fa0bc19-ba89-480b-979d-e5af7d15e972" }, { "id": "6b921a7e-f9d7-4ab2-85e6-372968c2e773", "drugName": "MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/6b921a7e-f9d7-4ab2-85e6-372968c2e773" }, { "id": "ee8ef817-5bd6-4538-97e9-dc7606c3cc1f", "drugName": "Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/ee8ef817-5bd6-4538-97e9-dc7606c3cc1f" }, { "id": "70b75eee-be9e-431d-8724-9174eea55a54", "drugName": "Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.", "manufacturer": "Lannett Company Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.", "url": "https://drugsmonitor.com/recall/70b75eee-be9e-431d-8724-9174eea55a54" }, { "id": "78402b8e-1524-4f4c-8d5d-9739e71af3da", "drugName": "FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4.", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/78402b8e-1524-4f4c-8d5d-9739e71af3da" }, { "id": "35cba24c-66b0-4231-84aa-9d4144f597c6", "drugName": "KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporat", "manufacturer": "Guardian Drug Co. Inc.", "dateOfAction": "20260610", "type": "Safety Label Change", "reason": "Presence of foreign substance: small metallic particles in chewable tablets.", "url": "https://drugsmonitor.com/recall/35cba24c-66b0-4231-84aa-9d4144f597c6" }, { "id": "222a4d10-e93b-4558-be49-3a0461aee412", "drugName": "Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.", "manufacturer": "AVEVA Drug Delivery Systems, Inc.", "dateOfAction": "20260603", "type": "Safety Label Change", "reason": "Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.", "url": "https://drugsmonitor.com/recall/222a4d10-e93b-4558-be49-3a0461aee412" }, { "id": "4c8a0720-02ef-4a89-892b-0641bd68b846", "drugName": "PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.", "manufacturer": "AbbVie Inc.", "dateOfAction": "20260603", "type": "Safety Label Change", "reason": "Failed Stability Specifications", "url": "https://drugsmonitor.com/recall/4c8a0720-02ef-4a89-892b-0641bd68b846" }, { "id": "080f2358-d8c3-449c-97ad-9b025654f4c5", "drugName": "Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01", "manufacturer": "Safecor Health, LLC", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.", "url": "https://drugsmonitor.com/recall/080f2358-d8c3-449c-97ad-9b025654f4c5" }, { "id": "c59fcbd3-ac7b-4bb3-b20c-f993417e5970", "drugName": "fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.", "manufacturer": "IntegraDose Compounding Services LLC", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Subpotent Drug", "url": "https://drugsmonitor.com/recall/c59fcbd3-ac7b-4bb3-b20c-f993417e5970" }, { "id": "01744b8e-0cf2-4b5a-afc0-5892307db83f", "drugName": "Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (", "manufacturer": "Zydus Pharmaceuticals (USA) Inc", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit", "url": "https://drugsmonitor.com/recall/01744b8e-0cf2-4b5a-afc0-5892307db83f" }, { "id": "6c6dc4c0-8fc5-4c46-b595-b76b100139b9", "drugName": "Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02", "manufacturer": "Lupin Pharmaceuticals Inc.", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Presence of particulate matter: a white thread-like structure in the cartridge", "url": "https://drugsmonitor.com/recall/6c6dc4c0-8fc5-4c46-b595-b76b100139b9" }, { "id": "ed1ca25a-a1bd-417e-8c23-9706b9797442", "drugName": "Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a", "manufacturer": "Zydus Pharmaceuticals (USA) Inc", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit", "url": "https://drugsmonitor.com/recall/ed1ca25a-a1bd-417e-8c23-9706b9797442" }, { "id": "92673600-0737-4ac5-b792-afe636be5b50", "drugName": "Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose", "manufacturer": "Amerisource Health Services LLC", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.", "url": "https://drugsmonitor.com/recall/92673600-0737-4ac5-b792-afe636be5b50" }, { "id": "80c393df-f5e9-4d73-8fe1-6dd4ee74fe04", "drugName": "Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05", "manufacturer": "Golden State Medical Supply Inc.", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.", "url": "https://drugsmonitor.com/recall/80c393df-f5e9-4d73-8fe1-6dd4ee74fe04" }, { "id": "e9a6c459-26c6-4d28-a22a-7e371c662690", "drugName": "Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01", "manufacturer": "Golden State Medical Supply Inc.", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.", "url": "https://drugsmonitor.com/recall/e9a6c459-26c6-4d28-a22a-7e371c662690" }, { "id": "527f82b8-fd5c-49d6-9818-113514976fa3", "drugName": "MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.", "manufacturer": "Wisconsin Pharmacal Company", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.", "url": "https://drugsmonitor.com/recall/527f82b8-fd5c-49d6-9818-113514976fa3" }, { "id": "76b39395-5683-4fe9-973f-851f7deda548", "drugName": "cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 ca", "manufacturer": "UCB Biosciences Inc.", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Lack of Assurance of Sterility", "url": "https://drugsmonitor.com/recall/76b39395-5683-4fe9-973f-851f7deda548" }, { "id": "632555a9-5319-4804-9d26-0338bd0e662b", "drugName": "Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose", "manufacturer": "Amerisource Health Services LLC", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.", "url": "https://drugsmonitor.com/recall/632555a9-5319-4804-9d26-0338bd0e662b" }, { "id": "1bf2b5f5-3df4-4301-b211-f5c40b689930", "drugName": "Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20", "manufacturer": "ANI Pharmaceuticals, Inc.", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Defective Container; packets were found to be either empty or partially full.", "url": "https://drugsmonitor.com/recall/1bf2b5f5-3df4-4301-b211-f5c40b689930" }, { "id": "3d8f3dd2-2bf7-4a99-8d2b-0523ec18a1b8", "drugName": "Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.", "manufacturer": "Sagent Pharmaceuticals", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Failed Impurities/Degradation Specifications", "url": "https://drugsmonitor.com/recall/3d8f3dd2-2bf7-4a99-8d2b-0523ec18a1b8" }, { "id": "78af3e5b-b1fc-4e7e-838c-9e48f538f80a", "drugName": "Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.", "manufacturer": "Lannett Company Inc.", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.", "url": "https://drugsmonitor.com/recall/78af3e5b-b1fc-4e7e-838c-9e48f538f80a" }, { "id": "6f81e034-390b-41b5-9929-bfec31eaefa8", "drugName": "Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.", "manufacturer": "Haleon US Holdings LLC", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.", "url": "https://drugsmonitor.com/recall/6f81e034-390b-41b5-9929-bfec31eaefa8" }, { "id": "f8cb3d14-d885-4e10-b226-b41b5dffb382", "drugName": "Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH.", "manufacturer": "Safecor Health, LLC", "dateOfAction": "20260527", "type": "Safety Label Change", "reason": "Presence of a Foreign Substance; black particles observed in liquid", "url": "https://drugsmonitor.com/recall/f8cb3d14-d885-4e10-b226-b41b5dffb382" }, { "id": "5b70554c-db45-4e11-81e7-d38c793183d1", "drugName": "Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6", "manufacturer": "Oasis Medical, Inc.", "dateOfAction": "20260520", "type": "Safety Label Change", "reason": "Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.", "url": "https://drugsmonitor.com/recall/5b70554c-db45-4e11-81e7-d38c793183d1" }, { "id": "f95017c8-b009-4168-9e6b-8c3d970f5c75", "drugName": "Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.", "manufacturer": "ENDO USA, Inc.", "dateOfAction": "20260520", "type": "Safety Label Change", "reason": "Presence of particulate matter: identified as Buprenorphine free base", "url": "https://drugsmonitor.com/recall/f95017c8-b009-4168-9e6b-8c3d970f5c75" }, { "id": "f7a52bce-e5f6-4f63-a1cb-28fa5c5d4774", "drugName": "Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ ", "manufacturer": "Ascend Laboratories, LLC", "dateOfAction": "20260520", "type": "Safety Label Change", "reason": "Failed Dissolution Specifications", "url": "https://drugsmonitor.com/recall/f7a52bce-e5f6-4f63-a1cb-28fa5c5d4774" } ] }