Browse Drug Recalls
61 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 61 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 61 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2025 | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. | Class II | RemedyRePack Inc. |
| Mar 24, 2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations | Class II | RemedyRepack Inc. |
| Jan 24, 2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister car... | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended a... | Class II | RemedyRepack Inc. |
| Dec 2, 2024 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | RemedyRepack Inc. |
| Jun 26, 2024 | Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... | CGMP Deviations: Out of specification for dissolution | Class II | RemedyRepack Inc. |
| May 31, 2024 | Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ... | Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbita... | Class II | RemedyRepack Inc. |
| May 2, 2024 | TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3... | Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported findin... | Class II | RemedyRepack Inc. |
| May 1, 2023 | LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | RemedyRepack Inc. |
| May 1, 2023 | Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | RemedyRepack Inc. |
| May 1, 2023 | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged ... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) ... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-0... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepac... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03)... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-0... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Mar 20, 2023 | Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01... | cGMP Deviations | Class II | RemedyRepack Inc. |
| Dec 20, 2022 | Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma,... | Failed Impurities/Degradation specifications | Class II | RemedyRepack Inc. |
| Dec 5, 2022 | Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315... | Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. | Class II | RemedyRepack Inc. |
| Sep 15, 2022 | Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, ... | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. | Class II | RemedyRepack Inc. |
| May 4, 2022 | Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repac... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | RemedyRepack Inc. |
| May 2, 2022 | Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged ND... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| May 2, 2022 | Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| Apr 6, 2022 | Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1)... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Class II | RemedyRepack Inc. |
| Dec 30, 2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | RemedyRepack Inc. |
| Dec 29, 2021 | Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b... | Failed Impurities/Degradation Specifications | Class II | RemedyRepack Inc. |
| Aug 17, 2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pen... | A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product w... | Class II | RemedyRepack Inc. |
| Oct 11, 2020 | Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx o... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | RemedyRepack Inc. |
| Jun 29, 2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... | Class II | RemedyRepack Inc. |
| Dec 27, 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... | Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer... | Class I | RemedyRepack Inc. |
| Dec 11, 2019 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... | CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts a... | Class II | RemedyRepack Inc. |
| Aug 5, 2019 | Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lu... | Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product c... | Class II | RemedyRepack Inc. |
| Apr 22, 2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | RemedyRepack Inc. |
| Mar 14, 2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmace... | Class II | RemedyRepack Inc. |
| Nov 7, 2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... | Cross contamination with other products: Product is being recalled due to the potential presence ... | Class III | RemedyRepack Inc. |
| Oct 26, 2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... | Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... | Class III | RemedyRepack Inc. |
| Aug 24, 2018 | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... | Class II | RemedyRepack Inc. |
| Aug 20, 2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Jul 17, 2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Jul 17, 2018 | Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
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.