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 |
|---|---|---|---|---|
| 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 |
| 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 | SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Wo... | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. | Class I | ANTHONY TRINH, 123Herbals LLC |
| Oct 20, 2025 | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emu... | Subpotent Drug | Class III | Imprimis NJOF, 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 |
| Oct 15, 2025 | Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcuta... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutan... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutan... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcu... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcuta... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcu... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcut... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 14, 2025 | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING 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.