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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) b... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-pack... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) ... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ ... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Mar 12, 2013 Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distribut... Failed Impurities/Degradation Specifications: 3 month stability testing. Class III L. Perrigo Co.
Feb 18, 2013 PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorp... Subpotent; 12 month time point for the active ingredient Phenylephrine HCl. Class III L. Perrigo Co.
Dec 17, 2012 Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 4... Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of th... Class II L. Perrigo Co.

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.