FDAFDA recall D-0014-2027 · Oct 14, 2026
Cipla USA, Inc.: Fosfomycin Tromethamine Granules for Oral Solution recall
Recall found
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot#: 5KA0405, Exp 12/31/2026.
- Quantity
- N/A
- Distribution
- USA Nationwide.
- Recalling firm
- Cipla USA, Inc., Warren, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-18
Source: openFDA enforcement record D-0014-2027 · search recall number D-0014-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.