Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 2, 2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodi... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointme... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manuf... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF St... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Fre... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Produ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. w... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15 | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aqu... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altai... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: C... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodiu... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jun 26, 2019 | PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, Firs... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Phar... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma As... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associat... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pha... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx on... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Assoc... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 m... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First P... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only,... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)1... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, F... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 19, 2019 | LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 3... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West S... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 3... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89;... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding,... | Lack of Assurance of Sterility | Class II | RXQ Compounding 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.