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
View recall →
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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Kairo's Group, Inc. dba Chuao Chocolatier
- Product
- chuao CHOCOLATIER potato chip mini chocolate bar, 0.39oz/11g
- Reason
- Undeclared hazelnut
- Published
- May 29, 2024
- Distribution
- U.S. distribution to distributors, retai…
View recall →
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
Reser's Fine Foods, Inc.
- Product
- Product is MACARONI Salad, but the bottom container is misla…
- Reason
- Undeclared Wheat. Aldi Macaroni Salad was mislabeled as Coleslaw and Coleslaw label does not declare wheat. Macaroni (pasta) is visible through a clear plastic package.
- Published
- May 29, 2024
- Distribution
- Distributed in AL, CT, FL, GA, LA, MA, M…
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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Graceleigh, Inc. dba Sammy's Milk
- Product
- Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick…
- Reason
- FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.
- Published
- May 29, 2024
- Distribution
- U.S. Distribution to the following state…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Graceleigh, Inc. dba Sammy's Milk
- Product
- Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch
- Reason
- FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe for use as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.
- Published
- May 29, 2024
- Distribution
- U.S. Distribution to the following state…
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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
View recall →
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
View recall →
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
View recall →
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
View recall →
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 →
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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