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 |
|---|---|---|---|---|
| Apr 2, 2019 | Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 31... | 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 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Ph... | 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 | 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 | Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 31... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding P... | 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 | 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 | Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310... | 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... |
| Apr 2, 2019 | Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compoundi... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff ... | 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 | 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 | 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 | Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy ... | 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 | Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City H... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Phar... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pha... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding ... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| 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 | Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City H... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Blu... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compoundi... | 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 | HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluf... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Mar 13, 2019 | Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Sol... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Soluti... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ... | Lack of Assurance of Sterility | Class II | Advanced Pharma Inc. |
| Mar 13, 2019 | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1... | Lack of Assurance of Sterility | Class II | Advanced Pharma 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.