0 — Class I drug recall D-0628-2025
Ongoing recall by B BRAUN MEDICAL INC, reported 2025-09-10, distributed nationwide. Presence of Particulate Matter.
| Recall number | D-0628-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B BRAUN MEDICAL INC, Allentown, PA, United States |
| Recall initiated | 2025-08-18 |
| Classified | 2025-09-10 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 47,148 containers |
| Reason classes | specification failure |
| NDC | 00264-7800, 00264-7800-09 |
| Lot numbers | V3K770 |
| Expiration dates | 2026-01-31 |
Product
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Reason for recall
Presence of Particulate Matter.
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-0628-2025. 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.