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 |
|---|---|---|---|---|
| Jul 21, 2025 | Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton... | Failed Dissolution Specifications: potential for delayed dissolution of the dose after administra... | Class II | Merck & Co. Inc |
| Jul 21, 2025 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx... | Failed Dissolution Specifications: low dissolution results | Class II | Ascend Laboratories, LLC |
| Jul 18, 2025 | Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 u... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 u... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 u... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 un... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 un... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 17, 2025 | KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 17, 2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol ... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 17, 2025 | DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bott... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 17, 2025 | PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) ... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 15, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 11, 2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Nostrum Laboratories, Inc. |
| Jul 10, 2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Beauty & Skincare Power Stick original nourishing invisible protection roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides... | Failed Dissolution Specifications. | Class II | Strides Pharma, Inc. |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... | Sub-Potent Drug: Subpotent assay results during stability testing. | Class II | Imprimis NJOF, LLC |
| Jul 9, 2025 | Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 | Subpotent Drug | Class III | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... | Sub-Potent Drug: Subpotent assay results during stability testing. | Class III | Imprimis NJOF, LLC |
| Jul 7, 2025 | H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China wi... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walm... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen,... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 5, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. | Class II | FDC Limited |
| Jul 2, 2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 i... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 1, 2025 | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated... | Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identifi... | Class II | Central Admixture Pharmacy Services, Inc (CAPS)... |
| Jun 30, 2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jun 30, 2025 | Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, M... | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250m... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 30, 2025 | Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... | Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. | Class II | Cipla USA, Inc. |
| Jun 27, 2025 | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... | Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 27, 2025 | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele... | Class I | Sandoz Inc |
| Jun 27, 2025 | Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial... | Class I | Sandoz 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.