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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.