FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
by Exela Pharma Sciences LLC
- Reason
- Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
M.O.M Enterprises, LLC.
- Product
- Organic BABY bedtime drops; sleep + immunity blend; Promotes…
- Reason
- Potential for spoilage due to yeast contamination.
- Published
- September 17, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Dynamic Sports Nutrition
- Product
- Anabolic Research WINN-50 (vanazolol). Dietary Supplement.…
- Reason
- Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
- Published
- September 17, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
by B BRAUN MEDICAL INC
- Reason
- Presence of Particulate Matter.
- Published
- September 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
by B BRAUN MEDICAL INC
- Reason
- Presence of Particulate Matter
- Published
- September 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
by Amneal Pharmaceuticals, LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
by Amneal Pharmaceuticals, LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
by Amneal Pharmaceuticals, LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 10, 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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