Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2025 | B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Glutathione Preserved for Injection, all strengths and presentations, GenoGen... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Glutathione Magnesium for Injection, all strengths and presentations, GenoGen... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LL... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 284... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 28... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 28... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 28... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentatio... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Calcium Chloride for Injection, all strengths and presentations, GenoGenix, L... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| 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 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 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. |
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.