Browse Drug Recalls
17,709 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,709 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 17,709 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2025 | Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL mu... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Magnesium Chloride for Injection, all strengths and presentations, GenoGenix,... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoG... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 N... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Reconstitution XO Solution for Injection, all strengths and presentations, Ge... | 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 | 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 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 24, 2025 | Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... | Failed Stability Specifications: Out of specification results was observed in Induction Port duri... | Class III | Cipla 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 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 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 | 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 |
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.