FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip Octoberfest Cookies: 4 oz / 114 grams…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip Hot Chip Summer Cookies: 4 oz / 114 gr…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip The Disco Ball Cookies: 4 oz / 114 gra…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip Fluffadoodle and Fluffa-Nutta Cookies:…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip Maple Macadamia Cookies: 4 oz / 114 g…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip Spiced Rum Oatmeal Raisin Cookies: 4 o…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip Spiced Oatmeal Raisin Cookies: 4 oz /…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip The Sweetie Cookies: 4 oz / 114 grams…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Chocolate and the Chip
- Product
- Chocolate & the Chip The Original Cookies: 4 oz / 114 grams…
- Reason
- Inspection by the California Department of Public Health found undeclared allergens in numerous bakery products.
- Published
- October 27, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
by Eli Lilly & Company
- Reason
- SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
- Published
- October 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
by Strides Pharma Inc.
- Reason
- Failed Dissolution Specifications
- Published
- October 20, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
by Akorn, Inc.
- Reason
- Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
- Published
- October 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
by Azurity Pharmaceuticals, Inc.
- Reason
- Product Mix-up: Incorrect diluent component included in the kit.
- Published
- October 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-10), Rx only, Mfg for: Amivas, LLC, 1209 Orange St., Wilmington, Delaware 19801.
by AMIVAS (US), LLC
- Reason
- Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
- Published
- October 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
by Alpha-Tek LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
- Published
- October 13, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
by SigmaPharm Laboratories LLC
- Reason
- Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
- Published
- October 6, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
by Washington Homeopathic Products, Inc.
- Reason
- Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- Published
- October 6, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
by Washington Homeopathic Products, Inc.
- Reason
- Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- Published
- October 6, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X, 9X, 12X,30X, packaged in 1 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 10X, 15X, 24X, 30X, packaged in 2 dr containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 30X, packaged in 2 oz containers, Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 6X, 7X, 8X, 10X, 12X, 15X, 16X, 18X, 30X, packaged in 4 dram containers, WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
by Washington Homeopathic Products, Inc.
- Reason
- Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- Published
- October 6, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, packaged in 100mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
by Washington Homeopathic Products, Inc.
- Reason
- Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- Published
- October 6, 2021
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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