FDA Recall
TerminatedTerminated: August 11, 2025Historical recordClass II
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
by Genentech, Inc.
- Reason
- Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 28, 2024Historical recordClass I
Hy-Vee Stores Inc
- Product
- Hy-Vee To Go Cookies & Cream Mix, Net wt. 4 oz (113g), UPC 0…
- Reason
- Potential Salmonella contamination
- Published
- June 5, 2024
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Nutrition Corp
- Product
- Fresh N Lean brand Crustless Chicken Potato Pot Pie. Package…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 9. 25pc Mother s Day heart ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 8. 16pc Mother s Day ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 7. 7pc Mother s Day heart box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 6. Mother s Day love purse
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 5. 9pc signature box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 4. 6pc signature ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 3. 4pc ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 2. 2pc signature Ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 21, 2025Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 1. 2pc Ganache tote box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 22, 2025Historical recordClass II
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
by American Regent, Inc.
- Reason
- Subpotent product in addition to having out-of-specification results for impurities.
- Published
- May 29, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
by SOMERSET THERAPEUTICS LLC
- Reason
- Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Published
- May 29, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 29, 2024
- Distribution
- Product distributed to CA, FL, OK, KS an…
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FDA Recall
OngoingHistorical recordClass III
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- May 29, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 17, 2024Historical recordClass III
Kairo's Group, Inc. dba Chuao Chocolatier
- Product
- chuao CHOCOLATIER potato chip mini chocolate bar, 0.39oz/11g
- Reason
- Undeclared hazelnut
- Published
- May 29, 2024
- Distribution
- U.S. distribution to distributors, retai…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 27, 2024Historical recordClass III
Natural Waters of Viti Limited
- Product
- Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code:…
- Reason
- Firm testing revealed Manganese in addition to three bacterial genera.
- Published
- May 29, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 7, 2024Historical recordClass II
Colonna Brothers Inc.
- Product
- Supreme Tradition brand and Marcum brand ground cinnamon. Pa…
- Reason
- Elevated lead levels in cinnamon
- Published
- May 29, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 24, 2024Historical recordClass I
Graceleigh, Inc. dba Sammy's Milk
- Product
- Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick…
- Reason
- FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.
- Published
- May 29, 2024
- Distribution
- U.S. Distribution to the following state…
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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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