FDA Recall
Ongoing
Historical recordClass II
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.
by Preferred Pharmaceuticals, Inc.
- Reason
- Failed Stability Specifications
- Published
- July 12, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
- Published
- July 12, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Supplement Manufacturing Partner, Inc.
- Product
- Havasu Beetroot Powder, 11.5 oz.
- Reason
- Contains undeclared milk
- Published
- July 12, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent drug
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
by Homeocare Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03
by Ferring Pharmaceuticals Inc
- Reason
- cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
by The Harvard Drug Group
- Reason
- Packaging defect: blister packaging inadequately sealed.
- Published
- July 5, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
- Published
- June 28, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
by Aurolife Pharma, LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 28, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
by AVKARE LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- June 21, 2023
- 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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