FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 1. 2pc Ganache tote box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
Ongoing
Historical 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
Terminated
Historical 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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical 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
Ongoing
Historical recordClass II
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
by Pharma Nobis LLC
- Reason
- Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
by Pharma Nobis LLC
- Reason
- Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
by Sagent Pharmaceuticals
- Reason
- Presence of Particulate Matter: Potential for black particulates in the drug product.
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
by MACLEODS PHARMA USA, INC
- Reason
- Presence of foreign substance: plastic-like substance.
- Published
- May 22, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Published
- May 22, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
by Lupin Pharmaceuticals Inc.
- Reason
- Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
- Published
- May 22, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
by Dercher Enterprises, Inc., DBA Gordon Laboratories
- Reason
- cGMP Deviations
- Published
- May 22, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
East West Tea Company, LLC
- Product
- Organic Yogi Echinacea Immune Support, Caffeine Herbal Suppl…
- Reason
- Organic Yogi Echinacea Immune Support product is recalled because pesticide residues were detected above action levels.
- Published
- May 22, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amphotericin B Liposome for Injection, 50mg vials, 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 62756-233-01
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Out of specification for assay
- Published
- May 15, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: Dotted and yellow spots on tablets
- Published
- May 15, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc.
- Reason
- Discoloration: Dotted and yellow spots on tablets
- Published
- May 15, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent drug
- Published
- May 15, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
by RemedyRePack Inc.
- Reason
- Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
- Published
- May 15, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
by Rubicon Research Private Limited
- Reason
- Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- Published
- May 15, 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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