Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 | 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 | Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, pr... | Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. | Class III | Johnson Matthey Inc. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluf... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anders... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 B... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy,... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL S... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Ander... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Sermorelin 0.4 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 | HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 2, 2019 | Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine... | Lack of sterility assurance. | Class II | Anderson Compounding Pharmacy, Inc. DBA Anderso... |
| Apr 1, 2019 | DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%),... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 6... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcoho... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 4... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 6... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Man... | Failed Impurities/Degradation Specifications; 18 month long term stability study. | Class III | Lupin Pharmaceuticals Inc. |
| Apr 1, 2019 | CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcoho... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
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.