Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 17, 2019 | Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... | Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 11, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... | Labeling: Missing label; Product complaints reported missing bottle label. | Class III | Lupin Pharmaceuticals Inc. |
| Jun 25, 2019 | Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U... | Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da... | Class III | AAA Pharmaceutical, Inc. |
| Jun 17, 2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... | Failed Stability Specifications: Out of specification for viscosity. | Class III | Bausch & Lomb |
| Jun 12, 2019 | Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... | Defective Container; actuator may improperly function and affect dose delivery. | Class III | InvaGen Pharmaceuticals, Inc. |
| Jun 7, 2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... | Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... | Class III | Akorn Inc |
| May 22, 2019 | Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... | Failed Impurities/Degradation Specifications. | Class III | Fresenius Kabi USA, LLC |
| May 20, 2019 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC ... | Failed Impurities/Degradation Specifications | Class III | Teligent Pharma, Inc. |
| May 10, 2019 | QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz... | Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material. | Class III | Ecolab Inc |
| Apr 29, 2019 | Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ... | Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax... | Class III | Pfizer Inc. |
| Apr 25, 2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2... | Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the n... | Class III | Advantice Health |
| Apr 25, 2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2... | Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rathe... | Class III | Advantice Health |
| Apr 23, 2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car... | Failed impurities/degradation specification: Out of Specification result for total impurity at 4.... | Class III | Akorn Inc |
| Apr 22, 2019 | Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by... | Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substan... | Class III | Zydus Pharmaceuticals USA Inc |
| Apr 10, 2019 | Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,... | Failed Impurities/Degradation Specifications | Class III | LUPIN SOMERSET |
| Apr 10, 2019 | Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,... | Failed Impurities/Degradation Specifications | Class III | LUPIN SOMERSET |
| Apr 10, 2019 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,... | Failed Impurities/Degradation Specifications | Class III | LUPIN SOMERSET |
| Apr 10, 2019 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... | Failed Impurities/Degradation Specifications | Class III | LUPIN SOMERSET |
| Apr 10, 2019 | Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufac... | Failed Impurities/Degradation Specifications | Class III | LUPIN SOMERSET |
| Apr 3, 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact... | Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) | Class III | AVKARE Inc. |
| 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 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (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 | 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 | 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 | 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 | ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl o... | 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 ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl ... | 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 | 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 | 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 | 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 | 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 BANANA SPLIT 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 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 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 | festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ing... | 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 | 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 | 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 | 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 | 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. |
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.