Browse Drug Recalls
68 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 68 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 68 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 2, 2019 | HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hw... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharma... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharma... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Phar... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compoundin... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Wat... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Sali... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 m... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff C... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, An... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
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.