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Browse Drug Recalls

310 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 310 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 310 FDA drug recalls.

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DateProductReasonClassFirm
Dec 5, 2012 Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single us... Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of p... Class II Teva Pharmaceuticals USA, Inc.
May 18, 2012 Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed b... Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particl... Class II Teva Pharmaceuticals USA, Inc.
May 16, 2012 Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactur... Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and o... Class II Teva Pharmaceuticals USA, Inc.
May 2, 2012 Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.... Impurities/Degradation: This recall is being carried out due to the potential for some lots not ... Class II Teva Pharmaceuticals USA, Inc.
Apr 24, 2012 CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA... Impurities/Degradation Products: This lot of product will not meet the impurity specification ove... Class III Teva Pharmaceuticals USA, Inc.
Apr 23, 2012 Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each... Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that s... Class III Teva Pharmaceuticals USA, Inc.
Apr 2, 2012 Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs p... Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. Class II Teva Pharmaceuticals USA, Inc.
Feb 20, 2012 PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEV... Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Class II Physicians Total Care, Inc.
Feb 20, 2012 PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEV... Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API. Class II Physicians Total Care, Inc.
Apr 8, 2011 Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count table... Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Spe... Class III Physicians Total Care, Inc.

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.