Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIAIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIAIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIAMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIAMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIICHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIICHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIICHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIICHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIDOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIDOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIDOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIDOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITexas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIfestpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIISPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIGood to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIAccent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-07-31FDA-DrugUcb, IncClass IIKeppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Failed Dissolution Specifications.
- 2019-07-31FDA-DrugLupin Pharmaceuticals Inc.Class IILisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
- 2019-07-31FDA-DrugLa Fresh Group, Inc.Class IILA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
- 2019-07-31FDA-DrugDercher Enterprises, Inc., DBA Gordon LaboratoriesClass IIMONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIPreferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16
cGMP Deviations: Products may have microbial contamination.
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief