Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fosfomycin Tromethamine Granules for Oral Solution Recalled by Ascend Laboratories, LLC Due to Failed Impurities/Degradation Specifications: Out-of-specification results observed for the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ascend Laboratories, LLC directly.
Affected Products
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Quantity: 99,516 sachets
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ascend Laboratories, LLC
Ascend Laboratories, LLC has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report