FDA Recall
Terminated
Historical recordClass I
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Superpotent Drug: Due to overfilling of drug powder
- Published
- April 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
by Esperion
- Reason
- Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
by Specialty Process Labs LLC
- Reason
- Failed Stability Specifications
- Published
- April 24, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
by AvKARE
- Reason
- Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
- Published
- April 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Tropicale Foods, Inc.
- Product
- Helados Mexico Premium Ice Cream Minis Variety Pack 12 bars…
- Reason
- Salmonella contamination
- Published
- April 24, 2024
- Distribution
- U.S distribution to the following: IL, K…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Abdallah Incorporated
- Product
- Abdallah Sea Salt Almond Alligators. Net Weight 8 ounces (2…
- Reason
- Sea Salt Almond Allegator candy has a back label for chocolate covered cherries.
- Published
- April 24, 2024
- Distribution
- CA, CO, IA, MI, MN, MO, MS. MT, NC, OK,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
AROMITALIA USA INC
- Product
- Aromitalia Malasia Coconut Paste + 35.27 oz milk-based mix,…
- Reason
- Coconut is declared in the ingredient list, but not declared in the contains statement in coconut paste.
- Published
- April 24, 2024
- Distribution
- The products were distributed to 6 domes…
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FDA Recall
Ongoing
Historical recordClass I
Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
by Eugia US LLC
- Reason
- Presence of Particulate Matter
- Published
- April 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
by Teva Pharmaceuticals USA, Inc
- Reason
- Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
by NATCO Pharma Limited
- Reason
- CGMP Deviations
- Published
- April 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Published
- April 17, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lidl US TRADING
- Product
- Deluxe brand Macarons Party Edition 35 pieces 455g (35 x 13g…
- Reason
- Undeclared Wheat, Soy, Egg, Milk, Tree Nuts (foreign language labeling)
- Published
- April 17, 2024
- Distribution
- Imported product directly shipped to a w…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Backstage Center DBA CTC Seller
- Product
- Alipotec Raiz de Tejocote dietary supplements, Net. Wt. 0.35…
- Reason
- The "Alipotec King" Alipotec Raiz de Tejocote product was found to contain toxic yellow oleander instead of tejocote.
- Published
- April 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES SWEET POTATO CASSEROLE CONTAINS: EGG, MILK PIES…
- Reason
- During an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES STRAWBERRY PIE INGREDIENTS: STRAWBERRY PIE FILL…
- Reason
- During an inspection by NCDA, the firm was notified that the product label fails to list any sub ingredients.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES SQUASH CASSEROLE CONTAINS: MILK, EGGS, SOY, FIS…
- Reason
- During an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Robeson Enterprises
- Product
- PIES & SIDES PUMPKIN PIE 10.5 oz INGREDIENTS: PUMPKIN FILLIN…
- Reason
- During an inspection by NCDA, the firm was notified that the product contains undeclared milk and eggs. The label fails to list any sub ingredients and the contain statement does not list milk or eggs.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES DOT'S POTATO BAKE 2lb INGREDIENTS: IDAHO POTATO…
- Reason
- During an inspection by NCDA, the firm was notified that the label fails to list any sub ingredients.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES PEACH PIE INGREDIENTS: PEACH PIE FILLING, SUGAR…
- Reason
- During an inspection by NCDA, the firm was notified that the label fails list any sub ingredients.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Robeson Enterprises
- Product
- PIES & SIDES MO' MONEY PIE INGREDIENTS: BLACK EYED PEAS, COL…
- Reason
- During an inspection by NCDA, the firm was notified that the label fails to declare the allergen soy as an ingredient. The firm was also notified that the label does not list any sub ingredients or the allergen soy in the contains statement.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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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