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Class II · ModerateActive recall

Fosfomycin Tromethamine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot#: 5KA0405, Exp 12/31/2026.
Where it was soldUSA Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059 foreign manufacturer
Brand nameFOSFOMYCIN TROMETHAMINE
Generic nameFOSFOMYCIN TROMETHAMINE
Active ingredient(s)FOSFOMYCIN TROMETHAMINE
Distributed by / forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
NDC69097-579-67
Show the full FDA record
Full product labelFosfomycin 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.
Recalling firmCipla USA, Inc.
DistributionUSA Nationwide.
QuantityN/A
Recall initiated2026-09-18
Report date2026-10-14
Recall completed—
Recall numberD-0014-2027
ClassificationClass II
FDA statusOngoing
Origin on fileWarren NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.