Browse Drug Recalls
6,322 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,322 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 6,322 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 2, 2019 | Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solutio... | 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 | Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 687... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 4953... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aq... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 m... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replen... | 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 | Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, N... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram... | 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 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodi... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 m... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | TRP Pink Eye Relief, 10 mL, NDC 17312-013-15 | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, R... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Conta... | 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. |
| 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 | 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 | 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 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 | 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 | 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 | 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 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 | 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 | 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 | 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 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 | 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 | 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 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 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 19, 2019 | PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoun... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compound... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compo... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding,... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | FOLIC ACID 10MG/ML INJECTION SOLUTION (MDV), 5 ML per vial, RXQ Compounding, ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30M... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compoundin... | 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.