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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Aug 10, 2020 BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01 Failed Impurity /Degradation Specifications Class II Par Pharmaceutical Inc.
Mar 30, 2020 Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Ph... Failed Impurities/Degradation Specification: Presence of unknown impurity observed. Class II Par Pharmaceutical Inc.
Mar 4, 2020 PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... Class III Par Pharmaceutical Inc.
Feb 10, 2020 Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio... Class III Par Pharmaceutical Inc.
Oct 26, 2015 Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct ... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Par Pharmaceutical Inc.
Oct 26, 2015 Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bot... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Par Pharmaceutical Inc.
Feb 12, 2015 Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams ste... Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene Class II Par Pharmaceutical Inc.
Nov 24, 2014 HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distr... Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydro... Class II Par Pharmaceutical 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.