Fosfomycin Tromethamine Granules for Oral Solution — Class III drug recall D-1145-2023
Terminated recall by Ascend Laboratories, LLC, reported 2023-09-13, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities
| Recall number | D-1145-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2023-07-18 |
| Classified | 2023-09-06 |
| Reported by FDA | 2023-09-13 |
| Terminated | 2026-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 99,516 sachets |
| Reason classes | specification failure |
| NDC | 67877-0749, 67877-0749-57 |
| Lot numbers | 22121970, 22121971, 22122158, 22122189, 22122190, 22122277, 22122278, 22122521, 22122522, 22122523, 22123328, 22123329, 22123330 |
| Expiration dates | 2024-06-20, 2024-07-20, 2024-09-20 |
Product
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1145-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.