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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Feb 9, 2018 Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5... Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Tors... Class II Apace KY LLC
Jun 19, 2017 Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, ... Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... Class II Apace KY LLC
Jun 19, 2017 Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose ... Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blist... Class II Apace KY LLC
Feb 12, 2016 Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Do... Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with a... Class III Apace KY LLC
Sep 4, 2012 Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, ... Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. Class III Apace KY 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.