drugs MODERATE Updated 2026-10-14

Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equival

See all recalls from Cipla USA, Inc. →

Recalled 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.

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Hazard / Issue

Failed Impurities/Degradation Specifications

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot#: 5KA0405, Exp 12/31/2026.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall