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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
Jan 15, 2026 methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton cont... Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blis... Class II Greenstone Llc
Apr 28, 2022 alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... Failed Dissolution Specifications: low out-of-specification dissolution test results observed. Class II Viatris Inc
Mar 15, 2021 medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Onl... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Sep 12, 2019 ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 20, 2018 Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx ... CGMP Deviations; rejected product was used to manufacture final bulk lot Class II Pfizer Inc.
Oct 20, 2017 diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m... SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class I Pfizer Inc.
Dec 17, 2014 Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 ... Subpotent Drug Class II Neolpharma, Inc.
Mar 6, 2014 Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottl... Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and ide... Class I Greenstone Llc
Jan 29, 2014 GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, ... Defective Container: Tamper evident ring failures discovered on some bottles. Class II Pfizer Inc.
Nov 5, 2013 sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Dist... Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36... Class II Greenstone LLC
Nov 4, 2013 Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, ... Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr... Class III Greenstone Llc
Nov 1, 2013 Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, ... Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Exten... Class II Greenstone Llc
Sep 4, 2013 Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By:... Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... Class II Greenstone Llc
Sep 4, 2013 Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By:... Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... Class II Greenstone 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.