FDA Recall
Terminated
Historical recordClass III
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
by AvKARE
- Reason
- Failed Dissolution Specifications
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sam'S Club
- Product
- Member's Mark Hatch Chile Chicken Enchiladas, ready to cook,…
- Reason
- Presence of Listeria monocytogenes
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Whole Carrots --- Organic Clip Carrots 50 Lbs C…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Whole Carrots --- Organic Carrot 125/6 Cal-Orga…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Baby Carrots --- Organic Baby Carrots 25 Grimmwa…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Baby Carrots --- Orangic Baby Peeled Carrots 13/…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Baby Carrots --- Organic Baby Peeled Carrots 12/…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
by RemedyRePack Inc.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
by Curium US, LLC
- Reason
- Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
- Published
- January 1, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
by Amerisource Health Services LLC
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
by Amerisource Health Services LLC
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
by Amerisource Health Services LLC
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
by Amerisource Health Services LLC
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
- Published
- January 1, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Zoe US, Inc.
- Product
- ZOE brand Daily 30+ Prebiotic blend; Dietary Supplement; 500…
- Reason
- Product may contain foreign objects: small metal pieces and/or stones
- Published
- January 1, 2025
- Distribution
- Arizona, California, Colorado, Connectic…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
by Macleods Pharmaceuticals Ltd
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 25, 2024
- 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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