Cipla USA Fosfomycin Tromethamine Granules for Oral Solution
Fosfomycin Tromethamine Granules for Oral Solution failed impurities and degradation specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Cipla USA, Inc. recalled Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, because it failed impurities and degradation specifications. The recall began September 18, 2026, and was added to the FDA's Enforcement Report and classified on October 6, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Fosfomycin Tromethamine Granules for Oral Solution
- NDC
- 69097-579-67
- Lot
- 5KA0405
Details
- Company began the recall
- Event ID
- 99930
- Company
- Cipla USA, Inc.
- Hazard
- Impurity or degradation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
