Recall D-0014-2027

US Class II Ongoing · initiated 2026-09-18

Recalling firm

Cipla USA, Inc., NJ

Product

Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.

Reason for recall

Failed Impurities/Degradation Specifications

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