FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Doehler North America, Inc.
- Product
- Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.3…
- Reason
- Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
- Published
- August 13, 2025
- Distribution
- Product was shipped to the following: Di…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 2, 2026Historical recordClass III
Cesarina Bakery, Inc
- Product
- SESAME SEED COOKIES Cesarina Cookies, Net Weight. 16 oz. (45…
- Reason
- Allergen not listed in the Contains statement: Sesame
- Published
- August 13, 2025
- Distribution
- Product was distributed in FL, GA, NC
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 2, 2026Historical recordClass II
Cesarina Bakery, Inc
- Product
- MEDITERRANEAN MIX COOKIES, Cesarina Cookies, Net Weight. 16…
- Reason
- Allergen not listed in the Contains statement: Sesame
- Published
- August 13, 2025
- Distribution
- Product was distributed in FL, GA, NC
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 21, 2026Historical recordClass I
Krasnyi Oktyabr USA Inc
- Product
- ARAL FISH; ARAL SILVER VOBLA; WHOLE DRIED, SALTED ROACH FISH…
- Reason
- Clostridium botulinum (uneviscerated fish)
- Published
- August 13, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 13, 2026Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Huckleberry Inte…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 13, 2026Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Pure. Intended u…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 13, 2026Historical recordClass II
QUEEN BEE GARDENS
- Product
- Brand Name: Queen Bee Gardens Whipped Honey Raspberry. Inte…
- Reason
- Product may have small flakes of stainless steel in product.
- Published
- August 13, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
by Hikma Pharmaceuticals USA Inc.
- Reason
- Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
by Nostrum Laboratories, Inc.
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
by Strides Pharma, Inc.
- Reason
- Failed Dissolution Specifications.
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
by Pfizer Inc.
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
by Pfizer Inc.
- Reason
- CGMP Deviations; particulates identified during visual inspection
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
by FDC Limited
- Reason
- Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 21, 2025Historical recordClass II
NuNaturals Inc
- Product
- Pure Monk Fruit Sweetener, net wt. 0.71oz. UPC 7 39223 00187…
- Reason
- Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 21, 2025Historical recordClass II
NuNaturals Inc
- Product
- Organic Pure Stevia, net wt. 1oz. UPC 7 39223 00204 0. Produ…
- Reason
- Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
- Published
- August 6, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 5, 2025Historical recordClass II
Moon N Sea GA LLC
- Product
- Yellow Fin Tuna, Net WT (variable weight) 50 lb brown corrug…
- Reason
- RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
- Published
- August 6, 2025
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 5, 2025Historical recordClass II
Moon N Sea GA LLC
- Product
- Blue Fin Tuna, Net WT (variable weight) 50 lb brown corrugat…
- Reason
- RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
- Published
- August 6, 2025
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 5, 2025Historical recordClass II
Moon N Sea GA LLC
- Product
- Fresh Scottish Salmon Fillet, Net WT (variable weight) 50 lb…
- Reason
- RTE fish (sushi-salmon, tuna) processed under insanitary conditions. The firm was notified by the Georgia Department of Agriculture that the products were manufactured under unsanitary conditions.
- Published
- August 6, 2025
- Distribution
- Products were shipped to the following s…
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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