Cipla recalls Fosfomycin Tromethamine Granules for Oral Solution because they failed impurity and degradation limits
The granules did not meet the required limits for impurities and degradation, and the notice does not say what this could do to a person.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- Cipla USA, Inc.
- Hazard
- Failed Impurities/Degradation Specifications
- Units
- N/A
- Where sold
- USA Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 6, 2026
- Recall started
- September 18, 2026
- FDA enforcement report
- October 14, 2026
- Identifiers
- Codes: Lot#: 5KA0405, Exp 12/31/2026.
- FDA recall number: D-0014-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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
- Classification
- Class II (Ongoing)
- Distribution
- USA Nationwide.
- Quantity
- N/A
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