Browse Drug Recalls
14,136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,136 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 14,136 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 |
| Oct 28, 2025 | Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusive... | Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren | Class II | Agebox |
| Oct 28, 2025 | Lisdexamfetamine Dimesylate Capsules, 70 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, 50 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, 60 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 27, 2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake... | Lack of Assurance of Sterility: Potential for flexible container leaks. | Class II | Otsuka ICU Medical LLC |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II | Cipla USA, Inc. |
| Oct 24, 2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... | Failed stability specifications: Out of specification for hardness test | Class II | Cipla USA, Inc. |
| Oct 23, 2025 | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. ... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- B... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 22, 2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bot... | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impuritie... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Oct 21, 2025 | Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (1... | Lack of Assurance of Sterility. | Class II | Bristol-Myers Squibb Company |
| Oct 21, 2025 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed b... | Defective Container | Class II | Kenvue Brands LLC |
| Oct 20, 2025 | NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Oct 17, 2025 | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet f... | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly state... | Class II | Aero Healthcare |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... | Class II | Amerisource Health Services LLC |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... | Class II | Amerisource Health Services LLC |
| Oct 16, 2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx on... | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the ... | Class II | Amerisource Health Services 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.