https://drugsmonitor.com/safety-hub FDA-oriented recall and safety actions from the DrugsMonitor cache. en-us Fri, 19 Jun 2026 00:40:21 GMT https://drugsmonitor.com/recall/cceebe82-ee82-4a03-a048-bd387e98b76b https://drugsmonitor.com/recall/cceebe82-ee82-4a03-a048-bd387e98b76b Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/6da95bbb-95c9-4afc-a912-050bb6ac31a3 https://drugsmonitor.com/recall/6da95bbb-95c9-4afc-a912-050bb6ac31a3 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/d8f0bc8a-0830-4067-811a-82537278400e https://drugsmonitor.com/recall/d8f0bc8a-0830-4067-811a-82537278400e Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/75bf0918-cd44-4233-ba4e-88b34f2381e7 https://drugsmonitor.com/recall/75bf0918-cd44-4233-ba4e-88b34f2381e7 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/a46af6f6-335a-4527-be91-8527f1a45e8d https://drugsmonitor.com/recall/a46af6f6-335a-4527-be91-8527f1a45e8d Invalid Date Lack of Assurance of Sterility https://drugsmonitor.com/recall/277e8a5b-a36e-4df3-9291-7218a80d7e2e https://drugsmonitor.com/recall/277e8a5b-a36e-4df3-9291-7218a80d7e2e Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/f31d3958-aa03-4af1-8a5b-f8e59fdd7b7e https://drugsmonitor.com/recall/f31d3958-aa03-4af1-8a5b-f8e59fdd7b7e Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/70ff6e85-8b29-4cc0-befc-9130256c6a15 https://drugsmonitor.com/recall/70ff6e85-8b29-4cc0-befc-9130256c6a15 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/252002d1-8364-4705-b2de-86e34e349ccf https://drugsmonitor.com/recall/252002d1-8364-4705-b2de-86e34e349ccf Invalid Date Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan https://drugsmonitor.com/recall/baab61ce-098a-4320-aa5c-7d3e6dffbd2e https://drugsmonitor.com/recall/baab61ce-098a-4320-aa5c-7d3e6dffbd2e Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/7994984e-eacd-410f-8b87-5744d9fdf95b https://drugsmonitor.com/recall/7994984e-eacd-410f-8b87-5744d9fdf95b Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/2ed800e7-1976-4828-8bf3-af4f61c3610e https://drugsmonitor.com/recall/2ed800e7-1976-4828-8bf3-af4f61c3610e Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/dd655f08-ec86-4742-ab69-0412e9eabe9c https://drugsmonitor.com/recall/dd655f08-ec86-4742-ab69-0412e9eabe9c Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/dda02d41-2596-4aac-91a8-b8ca8b64b6aa https://drugsmonitor.com/recall/dda02d41-2596-4aac-91a8-b8ca8b64b6aa Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/2e4f1af5-b4e8-4565-8715-7aa74d4cd4b3 https://drugsmonitor.com/recall/2e4f1af5-b4e8-4565-8715-7aa74d4cd4b3 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/dbe95da5-9848-4e85-a30a-5d32fe3a1f02 https://drugsmonitor.com/recall/dbe95da5-9848-4e85-a30a-5d32fe3a1f02 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/dcab59a4-5c7e-424d-a69b-3218b138da53 https://drugsmonitor.com/recall/dcab59a4-5c7e-424d-a69b-3218b138da53 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/a85300d4-0ea0-458b-8283-463ba9f7cec0 https://drugsmonitor.com/recall/a85300d4-0ea0-458b-8283-463ba9f7cec0 Invalid Date 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 https://drugsmonitor.com/recall/464defa2-554f-43ec-bf34-431d3edd4f02 https://drugsmonitor.com/recall/464defa2-554f-43ec-bf34-431d3edd4f02 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/f3233645-1482-4215-8921-32ae125e752c https://drugsmonitor.com/recall/f3233645-1482-4215-8921-32ae125e752c Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/0dc3e5a7-c5be-48c2-a33a-b5f005b5645e https://drugsmonitor.com/recall/0dc3e5a7-c5be-48c2-a33a-b5f005b5645e Invalid Date Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications https://drugsmonitor.com/recall/30e4cdf8-1eed-41ca-b726-08ae580fd15b https://drugsmonitor.com/recall/30e4cdf8-1eed-41ca-b726-08ae580fd15b Invalid Date CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. https://drugsmonitor.com/recall/e9fe3a61-40ba-4376-a976-3b5660d24e32 https://drugsmonitor.com/recall/e9fe3a61-40ba-4376-a976-3b5660d24e32 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/7fa0bc19-ba89-480b-979d-e5af7d15e972 https://drugsmonitor.com/recall/7fa0bc19-ba89-480b-979d-e5af7d15e972 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/6b921a7e-f9d7-4ab2-85e6-372968c2e773 https://drugsmonitor.com/recall/6b921a7e-f9d7-4ab2-85e6-372968c2e773 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/ee8ef817-5bd6-4538-97e9-dc7606c3cc1f https://drugsmonitor.com/recall/ee8ef817-5bd6-4538-97e9-dc7606c3cc1f Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/70b75eee-be9e-431d-8724-9174eea55a54 https://drugsmonitor.com/recall/70b75eee-be9e-431d-8724-9174eea55a54 Invalid Date Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. https://drugsmonitor.com/recall/78402b8e-1524-4f4c-8d5d-9739e71af3da https://drugsmonitor.com/recall/78402b8e-1524-4f4c-8d5d-9739e71af3da Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/35cba24c-66b0-4231-84aa-9d4144f597c6 https://drugsmonitor.com/recall/35cba24c-66b0-4231-84aa-9d4144f597c6 Invalid Date Presence of foreign substance: small metallic particles in chewable tablets. https://drugsmonitor.com/recall/222a4d10-e93b-4558-be49-3a0461aee412 https://drugsmonitor.com/recall/222a4d10-e93b-4558-be49-3a0461aee412 Invalid Date Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. https://drugsmonitor.com/recall/4c8a0720-02ef-4a89-892b-0641bd68b846 https://drugsmonitor.com/recall/4c8a0720-02ef-4a89-892b-0641bd68b846 Invalid Date Failed Stability Specifications https://drugsmonitor.com/recall/080f2358-d8c3-449c-97ad-9b025654f4c5 https://drugsmonitor.com/recall/080f2358-d8c3-449c-97ad-9b025654f4c5 Invalid Date Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. https://drugsmonitor.com/recall/c59fcbd3-ac7b-4bb3-b20c-f993417e5970 https://drugsmonitor.com/recall/c59fcbd3-ac7b-4bb3-b20c-f993417e5970 Invalid Date Subpotent Drug https://drugsmonitor.com/recall/01744b8e-0cf2-4b5a-afc0-5892307db83f https://drugsmonitor.com/recall/01744b8e-0cf2-4b5a-afc0-5892307db83f Invalid Date CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit https://drugsmonitor.com/recall/6c6dc4c0-8fc5-4c46-b595-b76b100139b9 https://drugsmonitor.com/recall/6c6dc4c0-8fc5-4c46-b595-b76b100139b9 Invalid Date Presence of particulate matter: a white thread-like structure in the cartridge https://drugsmonitor.com/recall/ed1ca25a-a1bd-417e-8c23-9706b9797442 https://drugsmonitor.com/recall/ed1ca25a-a1bd-417e-8c23-9706b9797442 Invalid Date CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit https://drugsmonitor.com/recall/92673600-0737-4ac5-b792-afe636be5b50 https://drugsmonitor.com/recall/92673600-0737-4ac5-b792-afe636be5b50 Invalid Date Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. https://drugsmonitor.com/recall/80c393df-f5e9-4d73-8fe1-6dd4ee74fe04 https://drugsmonitor.com/recall/80c393df-f5e9-4d73-8fe1-6dd4ee74fe04 Invalid Date Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. https://drugsmonitor.com/recall/e9a6c459-26c6-4d28-a22a-7e371c662690 https://drugsmonitor.com/recall/e9a6c459-26c6-4d28-a22a-7e371c662690 Invalid Date Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. https://drugsmonitor.com/recall/527f82b8-fd5c-49d6-9818-113514976fa3 https://drugsmonitor.com/recall/527f82b8-fd5c-49d6-9818-113514976fa3 Invalid Date Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. https://drugsmonitor.com/recall/76b39395-5683-4fe9-973f-851f7deda548 https://drugsmonitor.com/recall/76b39395-5683-4fe9-973f-851f7deda548 Invalid Date Lack of Assurance of Sterility https://drugsmonitor.com/recall/632555a9-5319-4804-9d26-0338bd0e662b https://drugsmonitor.com/recall/632555a9-5319-4804-9d26-0338bd0e662b Invalid Date Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. https://drugsmonitor.com/recall/1bf2b5f5-3df4-4301-b211-f5c40b689930 https://drugsmonitor.com/recall/1bf2b5f5-3df4-4301-b211-f5c40b689930 Invalid Date Defective Container; packets were found to be either empty or partially full. https://drugsmonitor.com/recall/3d8f3dd2-2bf7-4a99-8d2b-0523ec18a1b8 https://drugsmonitor.com/recall/3d8f3dd2-2bf7-4a99-8d2b-0523ec18a1b8 Invalid Date Failed Impurities/Degradation Specifications https://drugsmonitor.com/recall/78af3e5b-b1fc-4e7e-838c-9e48f538f80a https://drugsmonitor.com/recall/78af3e5b-b1fc-4e7e-838c-9e48f538f80a Invalid Date Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. https://drugsmonitor.com/recall/6f81e034-390b-41b5-9929-bfec31eaefa8 https://drugsmonitor.com/recall/6f81e034-390b-41b5-9929-bfec31eaefa8 Invalid Date Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. https://drugsmonitor.com/recall/f8cb3d14-d885-4e10-b226-b41b5dffb382 https://drugsmonitor.com/recall/f8cb3d14-d885-4e10-b226-b41b5dffb382 Invalid Date Presence of a Foreign Substance; black particles observed in liquid https://drugsmonitor.com/recall/5b70554c-db45-4e11-81e7-d38c793183d1 https://drugsmonitor.com/recall/5b70554c-db45-4e11-81e7-d38c793183d1 Invalid Date 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. https://drugsmonitor.com/recall/f95017c8-b009-4168-9e6b-8c3d970f5c75 https://drugsmonitor.com/recall/f95017c8-b009-4168-9e6b-8c3d970f5c75 Invalid Date Presence of particulate matter: identified as Buprenorphine free base https://drugsmonitor.com/recall/f7a52bce-e5f6-4f63-a1cb-28fa5c5d4774 https://drugsmonitor.com/recall/f7a52bce-e5f6-4f63-a1cb-28fa5c5d4774 Invalid Date Failed Dissolution Specifications