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Browse Drug Recalls

20 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 20 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 20 FDA drug recalls.

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DateProductReasonClassFirm
Jan 24, 2025 HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only... Failed Impurities/Degradation Specifications Class II SKY PACKAGING
Jan 24, 2025 HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactu... Failed Impurities/Degradation Specifications Class II SKY PACKAGING
Feb 12, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... Class II MCKESSON CORPORATION
Apr 21, 2022 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Mar 15, 2022 Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manuf... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Feb 7, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by:... Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Relat... Class II Teligent Pharma, Inc.
Nov 30, 2021 Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... Superpotent Drug Class I Teligent Pharma, Inc.
Nov 30, 2021 Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... Superpotent Drug: Minimally superpotent Class II Teligent Pharma, Inc.
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... Class II Teligent Pharma, Inc.
May 26, 2021 Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Dist... Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units b... Class III McKesson Corporation dba McKesson Drug Company
Feb 2, 2021 Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr... Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class III Teligent Pharma, Inc.
Jan 16, 2019 Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,... Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S... Class II Rx Pak Division of McKesson Corporation
Aug 14, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... Supterpotent Drug Class II Mckesson Corporation
Jan 29, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... Subpotent Drug: Out of specification for assay (stability testing) Class III Mckesson Packaging Services
Feb 23, 2017 Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 3... Presence of Foreign Substance: foreign material found in the bulk inventory. Class II Mckesson Packaging Services
Jun 19, 2014 Aspirin DR Enteric Coated Tablets, USP 325 mg, UD 750 tablets (25x30), Dist. ... Failed Dissolution Specification; at the 12 month time interval. Class III Mckesson Packaging Services

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.