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Browse Drug Recalls

51 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 51 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 51 FDA drug recalls.

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DateProductReasonClassFirm
Nov 17, 2025 Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Phar... Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... Class II Preferred Pharmaceuticals, Inc.
Apr 18, 2025 Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufacture... cGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Aug 8, 2024 Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... Failed Impurities/Degradation Specifications - at 18-month Stability testing Class II Preferred Pharmaceuticals, Inc.
May 10, 2024 Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred ... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Preferred Pharmaceuticals, Inc.
Jun 26, 2023 Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687... Failed Stability Specifications Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Acco... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accor... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufacture... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (ND... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Acc... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accor... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactu... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Jan 16, 2023 Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord He... Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a... Class II Preferred Pharmaceuticals, Inc.
May 3, 2022 Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Preferred Pharmaceuticals, Inc.
May 3, 2022 Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5,... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Preferred Pharmaceuticals, Inc.
Apr 12, 2022 Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, I... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class II Preferred Pharmaceuticals, Inc.
Mar 28, 2022 Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delay... Out of specification results observed in dissolution during long term stability testing. Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2022 Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bot... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2022 Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Pre... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2022 Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx O... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II Preferred Pharmaceuticals, Inc.
Feb 22, 2022 Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... CGMP deviations Class II Preferred Pharmaceuticals, Inc.
Nov 29, 2021 Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx ... Defective container: Out of specification for container integrity leading to bottles leaking. Class II Preferred Pharmaceuticals, Inc.
Apr 28, 2021 Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 ... CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily In... Class II Preferred Pharmaceuticals, Inc.
Apr 12, 2021 Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Susp... Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detec... Class II Preferred Pharmaceuticals, Inc.
Nov 1, 2020 Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyr... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyr... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyron... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Sep 2, 2020 Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) ... CGMP Deviations Class II Preferred Pharmaceuticals, Inc.
Jul 1, 2020 Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to... CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ... Class II Preferred Pharmaceuticals, Inc.
Jun 17, 2020 Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Nov 21, 2019 Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferre... Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Preferred Pharmaceuticals, Inc
Aug 29, 2019 Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackage... Failed Impurities/Degradation Specifications Class II Preferred Pharmaceuticals, Inc
Jul 18, 2019 Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II Preferred Pharmaceuticals, Inc
Jun 10, 2019 Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Preferred Pharmaceuticals, Inc
Apr 30, 2019 Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Preferred Pharmaceuticals, Inc
Mar 6, 2019 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-0... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. Class II Preferred Pharmaceuticals, 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.