Fosfomycin Tromethamine Recall: Cipla Granules NDC 69097-579-67
Announced 2026-10-14 · FDA
Recall involves Fosfomycin Tromethamine Granules for Oral Solution, 1 Single-Dose Sachet, Rx only, distributed nationwide in the USA. The recall is due to failed impurities/degradation specifications. Lot# 5KA0405, Exp 12/31/2026 is affected.
| Brand | 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 |
| Severity | moderate |
| Units affected | N/A |
| Distribution | USA Nationwide. |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you have Lot 5KA0405 (Exp 12/31/2026), stop using this product immediately.
- Do not take this medicine and contact your healthcare provider for guidance.
- Retain the packaging and contact the place of purchase or Cipla USA for disposal/return instructions.
- For more information, visit the FDA recall notice.
How to identify the recalled item
| Lot / date codes | Lot#: 5KA0405, Exp 12/31/2026. |
|---|---|
| Lot / date codes | Lot#: 5KA0405, Exp 12/31/2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.