FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Lowfat Yogurt with Toppers. Two-product package.…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Low Fat Yogurt with Toppers, Strawberry with milk c…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Low Fat Yogurt with Toppers, Vanilla with Chocolate…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Low Fat Yogurt with Toppers, Vanilla with Twix bar…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Low Fat Yogurt with Toppers, Vanilla with Snickers…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Lowfat Yogurt with Toppers, Vanilla with milk choco…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Prestige Brands Holdings
- Product
- Little Remedies¿ Honey Cough 4 FL OZ (118 mL)
- Reason
- contaminated with Bacillus cereus and may be spoiled
- Published
- July 23, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- July 16, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
by Macleods Pharmaceuticals Ltd
- Reason
- Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
- Published
- July 16, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- JLM Manufacturing Dark Chocolate Nonpareils, 14oz clear plas…
- Reason
- Undeclared milk
- Published
- July 16, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
by Sandoz Inc
- Reason
- Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
by Sandoz Inc
- Reason
- Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
by AvKARE
- Reason
- Failed Impurity/Degradation Specifications
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
by AvKARE
- Reason
- Failed Impurity/Degradation Specifications
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
by Granules Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
by The Harvard Drug Group LLC
- Reason
- Defective container; blister packaging inadequately sealed.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
by The Harvard Drug Group LLC
- Reason
- Defective container; blister packaging inadequately sealed.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
by Church & Dwight Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
by Church & Dwight Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
by Church & Dwight Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- Published
- July 9, 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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