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.
Failed Impurities/Degradation Specifications
| Recalling firm | Cipla USA, Inc. |
|---|---|
| Reason | Failed Impurities/Degradation Specifications |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Sep 18, 2026 |
| Region | NJ, United States |
| Distribution | USA Nationwide. |
| Quantity | N/A |
| Code/Lot | Lot#: 5KA0405, Exp 12/31/2026. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0014-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0014-2027)
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