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Browse Drug Recalls

22 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 22 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 22 FDA drug recalls.

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DateProductReasonClassFirm
Apr 11, 2023 Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... Lack of Assurance of Sterility: Malformed crimped collar seal Class II Sanofi-Aventis U.S. LLC
Aug 10, 2020 Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... Failed Stability Specifications: Out of Specification result for enzyme activity levels noted dur... Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chatt... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Jul 5, 2018 Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection,... Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. Class II Sanofi-Aventis U.S. LLC
Apr 27, 2018 Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. ... Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have be... Class II Sanofi-Aventis U.S. LLC
Dec 5, 2017 Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count ... Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found p... Class III Sanofi-Aventis U.S. LLC
Oct 13, 2017 Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T... Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the i... Class III Sanofi-Aventis U.S. LLC
Jun 12, 2017 Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor C... Superpotent Drug: high out-of-specification result for magnesium. Class III Sanofi-Aventis U.S. LLC
Sep 1, 2016 Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... Labeling: Incorrect or Missing Package Insert Class III Sanofi-Aventis U.S. LLC
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled au... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. LLC
Oct 28, 2015 Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled aut... Defective Delivery System; potential to have inaccurate dosage delivery Class I Sanofi-Aventis U.S. 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.