Browse Drug Recalls
378 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 378 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 378 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (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 | TOOTSIE ROLL 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 | CHARMS BLOW POP BLUE RAZZ BERRY 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 | Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcoh... | 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. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Mar 4, 2019 | ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 ... | Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contain... | Class III | Petra Hygienic Systems Int Ltd |
| Mar 1, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Bli... | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Class II | Apotex Inc. |
| Jan 11, 2019 | Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... | Defective Container; complaints of leakage. | Class III | Oxalis Labs |
| Dec 4, 2018 | Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, M... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manuf... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bott... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Ma... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, M... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottl... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manu... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, M... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manuf... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manu... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bott... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Dec 4, 2018 | Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle... | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... | Class II | Mylan Laboratories Limited, (Nashik FDF) |
| Oct 24, 2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Aurobindo Pharma Limited (Unit I) |
| Jul 18, 2018 | Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... | Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted... | Class II | Hetero Labs, Ltd. - Unit III |
| Jul 17, 2018 | Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (ND... | CGMP Deviations | Class II | Longbow First Aid Products Manufactory |
| Jul 17, 2018 | Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (... | CGMP Deviations | Class II | Longbow First Aid Products Manufactory |
| May 31, 2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... | Presence of foreign substance: glass particles | Class II | Apotex 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.