FDA Recall
OngoingHistorical recordClass III
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
by Qualgen, LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 2, 2026Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Lowfat Yogurt with Toppers Two-product package. Co…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 2, 2026Historical 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
TerminatedTerminated: February 2, 2026Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Lowfat Yogurt with Toppers. Two-product packages.…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 2, 2026Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Low Fat Yogurt with Toppers, Strawberry with Granol…
- Reason
- Foreign material (plastic pieces)
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 2, 2026Historical recordClass II
DANONE US LLC
- Product
- YoCrunch Low Fat Yogurt with toppers. Vanilla with Oreo coo…
- Reason
- Foreign material (plastic)
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 11, 2025Historical recordClass III
CinFranky LLC dba New Mexico Pinon Coffee
- Product
- New Mexico Pinon Coffee. Dark Pinon Single Serve 10ct. Produ…
- Reason
- Clear coat seal on the lid of the single serve cups did not get applied consistently to all cups in the production run. This resulted in the food safe ink printing on some cups to run when exposed to high temperature, high-pressure water used in a K-cup machine.
- Published
- July 23, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 2, 2026Historical 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
TerminatedTerminated: February 2, 2026Historical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 2, 2026Historical 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
TerminatedTerminated: February 2, 2026Historical 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
TerminatedTerminated: February 2, 2026Historical 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
TerminatedTerminated: February 2, 2026Historical 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
OngoingHistorical 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
OngoingHistorical 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
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FDA Recall
OngoingHistorical 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
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 19, 2025Historical 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
OngoingHistorical 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
OngoingHistorical 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 →
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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