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Browse Drug Recalls

63 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 63 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 63 FDA drug recalls.

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DateProductReasonClassFirm
Nov 22, 2019 Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Oct 16, 2019 Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10... Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. Class III Amneal Pharmaceuticals, Inc.
Sep 24, 2019 Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by... Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle Class III Amneal Pharmaceuticals, Inc.
Jul 18, 2019 Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) ... Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergono... Class III Amneal Pharmaceuticals, Inc.
Feb 26, 2018 RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... Failed Stability Specifications Class II Mckesson Packaging Services
Dec 15, 2017 Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distribut... Presence of particulate matter Class II Amneal Pharmaceuticals
Sep 25, 2017 Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100... Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... Class III Amneal Pharmaceuticals, Inc.
Sep 25, 2017 Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-c... Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone t... Class III Amneal Pharmaceuticals, Inc.
Aug 31, 2017 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Si... Presence of Particulate Matter Class II Amneal Pharmaceuticals LLC
Aug 3, 2017 Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured... Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. Class I Amneal Pharmaceuticals of New York, LLC
Dec 12, 2016 Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65... Failed Dissolution Specifications Class II Amneal Pharmaceuticals LLC
Aug 17, 2013 Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amne... Failed dissolution specifications; 18 month CRT Class II Amneal Pharmaceuticals of New York, 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.