Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026

Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx…

Cipla USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730

Is this the product you have?

  • Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only
  • Manufactured byCipla Ltd., Kurkumbh-413802, Maharashtra, India
  • Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67
Lot codes and dates
    • Lot#: 5KA0405
    • Exp 12/31/2026
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Nov 4, 12:12 AM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.