FDA Recall
Ongoing
2026 recordClass II
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Dissolution Specifications
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass III
FlavorsandColor.Com
- Product
- Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5…
- Reason
- Undeclared Red #40.
- Published
- August 19, 2026
- Distribution
- Product is sold to independent manufactu…
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FDA Recall
Ongoing
2026 recordClass II
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass I
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
by Sunny Pharmtech Inc.
- Reason
- Presence of Particulate Matter; identified as stainless steel
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass I
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
by Sunny Pharmtech Inc.
- Reason
- Presence of Particulate Matter; identified as stainless steel
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
by Aurobindo Pharma USA Inc
- Reason
- shortfill; reports of empty capsules.
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
PT Organics Limited
- Product
- Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit…
- Reason
- Possible foreign object (thin, soft plastic strands).
- Published
- August 12, 2026
- Distribution
- Distributed in AL, AZ, CA, CO, GA, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass I
AKKARCO LLC
- Product
- Ashfiat Alharamain Energy Support 250ml/8fl. oz.
- Reason
- Undeclared tadalafil
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
CHEER PACK
- Product
- Flexible food pouch (3-layer foil, spouted, #CP6088), manufa…
- Reason
- Flexible food pouch may release thin plastic strips into food.
- Published
- August 12, 2026
- Distribution
- only in OR.
View recall →
FDA Recall
Ongoing
2026 recordClass III
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.
by MYLAN PHARMACEUTICALS INC
- Reason
- Presence of precipitate
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.
by MICRO LABS USA INC
- Reason
- Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Mellish Island Corp
- Product
- Mellish Island Super Skin; Dietary Supplement; 60 Capsules,…
- Reason
- Firm's finished product label does not declare the source of marine collagen which was determined to be fish.
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
by Supernus Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications
- Published
- July 29, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
by Bionpharma Inc.
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- July 29, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
by Precision Dose Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- July 29, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
by Ascend Laboratories, LLC
- Reason
- Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
- Published
- July 29, 2026
- 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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