Browse Drug Recalls

33 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 33 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 33 FDA drug recalls.

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DateProductReasonClassFirm
Mar 26, 2026 Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, ... Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no... Class II Hetero Labs Limited (Unit V)
Oct 1, 2025 Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dos... Presence of Particulate Matter: Particulate matter identified as glass Class II Aspiro Pharma Limited
Nov 15, 2024 Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by... Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 ... Class II Evaric Pharmaceuticals Inc.
Mar 13, 2023 Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... Class I Camber Pharmaceuticals Inc.
Dec 6, 2022 Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Onl... Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid c... Class III Camber Pharmaceuticals, Inc
Nov 19, 2021 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... Product Mix-up Class II Ascent Pharmaceuticals, Inc.
Oct 26, 2020 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count b... Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablet... Class II Ascent Pharmaceuticals, Inc.
Aug 6, 2020 Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufacture... Failed Tablet/Capsule Specification; complaint of bulging tablet Class II Hetero Labs Limited (Unit V)
Mar 1, 2019 Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class II Legacy Pharmaceutical Packaging LLC
Mar 1, 2019 Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distribut... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class II Legacy Pharmaceutical Packaging LLC
Mar 1, 2019 Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distrib... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected Class II Legacy Pharmaceutical Packaging LLC
Feb 28, 2019 Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90... CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... Class II Camber Pharmaceuticals Inc
Feb 28, 2019 Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-3... CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... Class II Camber Pharmaceuticals Inc
Feb 28, 2019 Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30... CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... Class II Camber Pharmaceuticals Inc
Sep 12, 2018 Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for:... Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-min... Class III Hetero Labs, Ltd. - Unit III
Aug 20, 2018 Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, H... Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tabl... Class II Hetero Labs Limited Unit V
Aug 15, 2018 Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero... Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ... Class I Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Aug 8, 2018 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Hetero Labs Limited Unit V
Jul 18, 2018 Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted... Class II Hetero Labs, Ltd. - Unit III
Feb 13, 2018 Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured... Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were ex... Class II Hetero Labs Limited Unit V
Feb 13, 2018 Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for C... Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were ex... Class II Hetero Labs Limited Unit V
Jan 22, 2018 Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf... Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol Class III Ascent Pharmaceuticals, Inc.
Jan 10, 2018 Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II Hetero Labs, Ltd. - Unit III
Dec 22, 2017 Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for... Presence of foreign substance: metallic razor blade was found in one bottle. Class III Hetero Labs, Ltd. - Unit III
Oct 12, 2017 Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) ... Presence of foreign substance (screw) Class II Hetero Labs, Ltd. - Unit III
Jul 20, 2017 Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for... Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/... Class II Hetero USA Inc
Apr 27, 2017 Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: ... Presence of Foreign Substance: human hair melded into tablet. Class III Hetero USA Inc
Jan 7, 2017 Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for... Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue ... Class III Hetero USA Inc
Dec 29, 2016 Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : ... Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of p... Class III Hetero Drugs Ltd. - Unit 1
Apr 22, 2013 Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufact... Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine ... Class II Legacy Pharmaceutical Packaging 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.