Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 17, 2025 | BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and I... | Lack of Assurance of Sterlity | Class II | CareFusion 213, LLC |
| Dec 16, 2025 | Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, M... | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... | Class III | Alembic Pharmaceuticals Limited |
| Dec 16, 2025 | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx o... | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Class II | SpecGx, LLC |
| Dec 16, 2025 | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx onl... | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Class II | SpecGx, LLC |
| Dec 15, 2025 | MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafi... | Class I | StuffbyNainax |
| Dec 15, 2025 | Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactur... | Failed Impurities/Degradation Specifications | Class III | NOVADOZ PHARMACEUTICALS LLC |
| Dec 12, 2025 | Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg,... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Dec 12, 2025 | ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura... | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mo... | Class I | Medinatura New Mexico, inc. |
| Dec 12, 2025 | Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Onl... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Dec 12, 2025 | ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, ... | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mo... | Class I | Medinatura New Mexico, inc. |
| Dec 9, 2025 | Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., O... | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint | Class II | SUN PHARMA /TARO |
| Dec 8, 2025 | ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, S... | cGMP Deviations | Class II | Signature Formulations, LLC |
| Dec 8, 2025 | ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, ... | cGMP Deviations | Class II | Signature Formulations, LLC |
| Nov 26, 2025 | Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applica... | Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, F... | Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle ... | Class III | Winder Laboratories, LLC |
| Nov 26, 2025 | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... | Subpotent product:out of specification assay results observed during long term stability testing. | Class III | SOMERSET THERAPEUTICS LLC |
| Nov 26, 2025 | Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, ... | Presence of Foreign Tablets/Capsules | Class II | Golden State Medical Supply Inc. |
| Nov 24, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Nov 24, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Onl... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Nov 21, 2025 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... | Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 20, 2025 | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Op... | Incorrect Product Formulation | Class II | Fagron Compounding Services |
| Nov 18, 2025 | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... | Cross Contamination with Other Products | Class III | Glenmark Pharmaceuticals Inc., USA |
| 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. |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 14, 2025 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | Cipla USA, Inc. |
| Nov 13, 2025 | Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... | Failed impurities/degradation specifications: out of specification results for Ganirelix acetate ... | Class II | Lupin Pharmaceuticals Inc. |
| Nov 12, 2025 | Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED ... | Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis | Class II | Medical Products Laboratories, Inc. |
| Nov 11, 2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 7, 2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... | Defective Container - A defect in the side-seal which allows leakage of product. | Class III | Teva Pharmaceuticals USA, Inc |
| Nov 6, 2025 | Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only... | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Class I | Fresenius Kabi USA, LLC |
| Nov 5, 2025 | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Ma... | Defective container - seal not adhering to bottles | Class II | Lupin Pharmaceuticals Inc. |
| Oct 31, 2025 | WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Co... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for:... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Inj... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, U... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Di... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals,... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a cart... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Tri... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carto... | Failed Stability Specifications: Observed OOS results: eg results for colour index | Class II | Cipla Limited |
| Oct 31, 2025 | Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Niv... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI ... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Gle... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Me... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporatio... | cGMP deviations | Class II | Blossom Pharmaceuticals |
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.