Lactated Ringer's Injection USP — Class II drug recall D-0585-2025
Ongoing recall by B BRAUN MEDICAL INC, reported 2025-08-20, distributed nationwide. Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
| Recall number | D-0585-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B BRAUN MEDICAL INC, Allentown, PA, United States |
| Recall initiated | 2025-08-04 |
| Classified | 2025-08-14 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 74,088 containers |
| Reason classes | sterility, packaging |
| NDC | 00264-7750, 00264-7750-00, 00264-7750-10, 00264-7750-20 |
| Lot numbers | J5C802, J5C917, J5C918 |
| Expiration dates | 2027-08-31 |
Product
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Reason for recall
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
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-0585-2025. 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.