FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FGF, LLC
- Product
- item 8201811 OLD FASHIONED NATURALLY AND ARTIFICIALLY FLAVOR…
- 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 8201810 FLUFF BAR 78x2.75 OZ, NET WT 12.07 LB
- 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 8201809 PLAIN CAKE DONUT 108x2.25 OZ, NET WT 13.67 LB
- 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 8201808 PERSIAN DONUT 78x2.25 OZ, NET WT 9.87 LB
- 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 8201807 BAVARIAN FILLED DONUT 78x2.75OZ, NET WT 12.07 L…
- 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 8201806 RASPBERRY FILLED DONUT 78x2.75OZ, NET WT 12.07…
- 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 8201805 APPLE FRITTER 60x2.5 OZ, NET WT 8.44 LB
- 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 8201804 Yeast Ring Donut 108x2.15OZ, NET WT 13.06 LB
- 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 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 →
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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