0 — Class II drug recall D-0491-2025
Ongoing recall by B BRAUN MEDICAL INC, reported 2025-07-02, distributed nationwide. Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting
| Recall number | D-0491-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B BRAUN MEDICAL INC, Allentown, PA, United States |
| Recall initiated | 2025-06-16 |
| Classified | 2025-06-24 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 187,656 containers |
| Reason classes | sterility, packaging |
| NDC | 00264-7800, 00264-7800-00, 00264-7800-10, 00264-7800-20, 00264-7802, 00264-7802-00, 00264-7802-10 |
| Lot numbers | J4L260, J4L261, J4L270, J4L271, J4L280 |
| Expiration dates | 2027-02-28 |
Product
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Reason for recall
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
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-0491-2025. 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.