Browse Drug Recalls
14,572 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,572 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 14,572 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2025 | CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intrave... | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the imp... | Class II | Exela Pharma Sciences LLC |
| Jul 30, 2025 | Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 28... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Semaglutide with B12 for Injection, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and present... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Sterile Saline Reconstitution Solution for Injection, all strengths and prese... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL M... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 29, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Amerisource Health Services LLC |
| Jul 29, 2025 | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx onl... | Subpotent drug | Class II | Pfizer |
| Jul 25, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, R... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 25, 2025 | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactur... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Alembic Pharmaceuticals Limited |
| Jul 22, 2025 | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 22, 2025 | BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chlori... | Lack of Assurance of Sterility. | Class II | Taizhou Kangping Medical Science And Technology... |
| Jul 21, 2025 | Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per ca... | cGMP Deviations | Class II | YANGZHOU YULOU PAPER PRODUCTS CO., LTD |
| 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 | 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 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 | 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 | 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 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 injection solution, 2.21 mg + 0.25mg/0.5 mL Inj ... | 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 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 | 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 | 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 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 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 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 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... | 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 | 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 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. |
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.