Fosfomycin Tromethamine Granules for Oral Solution — Class II drug recall D-0339-2024
Ongoing recall by Ascend Laboratories, LLC, reported 2024-02-28, distributed nationwide. Failed Impurities/Degradation Specification: Out of specification for organic impurities
| Recall number | D-0339-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2024-01-16 |
| Classified | 2024-02-20 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 71,244 sachets |
| Reason classes | specification failure |
| NDC | 67877-0749, 67877-0749-57 |
| Lot numbers | 22121176, 22121407, 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, 22121465, 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969 |
| Expiration dates | 2024-03, 2024-04, 2024-05 |
Product
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), 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 Specification: Out of specification for organic impurities
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-0339-2024. 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.