Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution
- Recalling company
- Cipla USA, Inc.
- 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
- Failed Impurities/Degradation Specifications
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 18, 2026
- Reported
- Oct 14, 2026
- Distribution
- USA Nationwide.
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- Lot#: 5KA0405, Exp 12/31/2026.
- Company location
- Warren, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0014-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0014-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.