Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 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 | Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M ... | 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 | TRP Stye Relief, 4 g, NDC 17312-014-13 | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 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 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 | 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/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 | 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 | 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 | 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 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 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 | HYDROGEN PEROXIDE 3% INJECTABLE PFV, 30 ML per vial, RXQ Compounding, 340 Wes... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| 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 | MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compo... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compoun... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State... | 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 | 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 | TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per d... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Str... | 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 | 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 | MOLYBDENUM 0.025MG/ML INJECTION SOLUTION, 10ML per vial, RXQ Compounding, 340... | 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 | BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compoun... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 34... | 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 | PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Com... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compo... | 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 | STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EPINEPHrine 4MG ADDED TO D5W 5%, 250 ML per bag, RXQ Compounding, 340 West St... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Comp... | 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 | 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 | 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 | Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West ... | 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.