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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6 FDA drug recalls.

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DateProductReasonClassFirm
Sep 27, 2011 Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to cont... Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexo... Class II Shamrock Medical Solutions Group LLC
Sep 27, 2011 Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx... Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400... Class II Shamrock Medical Solutions Group LLC
Sep 27, 2011 Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiam... Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules Class I Shamrock Medical Solutions Group LLC
Sep 27, 2011 Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as M... Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE... Class I Shamrock Medical Solutions Group LLC
Sep 27, 2011 Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to conta... Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calc... Class II Shamrock Medical Solutions Group LLC
Sep 27, 2011 metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate... Labeling: Label Mix up; product labeled did not indicated Extended Release Class I Shamrock Medical Solutions Group LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.