FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201780 GEN CHOC CK DONUT RINGS PFD 90x2.5OZ, NET WT12.…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201779 GEN PLN CAKE DONUT RINGS PFD 90x2.5 OZ, NET WT…
- Reason
- potential for contamination with listeria monocytogenes
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Monkey Spit
- Product
- Monkey Spit "Monkey Mop" BBQ Sauce, 12 fl oz (355ml) glass b…
- Reason
- Barbeque sauce product contains undeclared listing of (Milk) in product ingredient listing from sub-ingredient Butter.
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Monkey Spit
- Product
- Monkey Spit "Atomic Mop" BBQ Sauce, 12 fl oz (355ml) glass b…
- Reason
- Barbeque sauce product contains undeclared allergen listing of (Milk) in product ingredient listing from sub-ingredient Butter.
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Monkey Spit
- Product
- Monkey Spit "Swamp Mop" BBQ Sauce, 12 fl oz (355ml) glass bo…
- Reason
- Barbeque sauce product contains undeclared allergens (soy) contained in sub-ingredient
- Published
- February 12, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01
by McKesson
- Reason
- cGMP Deviations: Product intended for quarantine was inadvertently distributed.
- Published
- February 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
- Published
- February 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.
by Astellas Pharma US Inc.
- Reason
- Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Published
- February 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73.
by Astellas Pharma US Inc.
- Reason
- Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
- Published
- February 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
by The W.S. Badger Company, Inc.
- Reason
- Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
- Published
- February 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Mochi Ice Cream Company
- Product
- My Mochi Sorbet Peach Mango Sorbet; Keep Frozen; 6 pieces pe…
- Reason
- Frozen Peach Mango Sorbet contains undeclared allergen (egg)
- Published
- February 5, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
by Appco Pharma LLC
- Reason
- Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
- Published
- January 29, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
by SHOPPERS- PLAZA
- Reason
- Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
- Published
- January 29, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
by First Aid Beauty Ltd
- Reason
- CGMP Deviations; product intended for quarantine was inadvertently distributed
- Published
- January 29, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
by Brands International Corporation
- Reason
- CGMP Deviations: lack of adequate release testing.
- Published
- January 29, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
by Viatris Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
by Viatris Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications:
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
by Amerisource Health Services LLC
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
by Alcon Research LLC
- Reason
- Non-Sterility
- Published
- January 22, 2025
- 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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