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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
May 18, 2023 Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by... Failed Impurities/Degradation Specifications Class III Aurolife Pharma, LLC
Dec 16, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Auro... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Mar 17, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by:... Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which ... Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equa... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distribute... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carto... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, D... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton,... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Au... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Ma... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, D... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Di... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count carto... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, 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.