Browse Drug Recalls
17,528 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,528 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 17,528 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 31, 2025 | Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [M... | Defective container: cracked/broken cartridges | Class II | Novocol Pharmaceutical of Canada, Inc. |
| Oct 31, 2025 | Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dyn... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnar... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protect... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 31, 2025 | Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (5... | cGMP deviations | Class II | Blossom Pharmaceuticals |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con... | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... | Class I | Otsuka ICU Medical LLC |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co... | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... | Class I | Otsuka ICU Medical LLC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Ex... | Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren | Class II | Agebox |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, ... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES 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.