Multi event Drug Recall Enforcement Report Class II voluntary initiated by B BRAUN MEDICAL INC, originally initiated on 08-04-2025 for the 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. The product was recalled due to lack of assurance of sterility; potential for fluid leakage at one of the weld sites.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0585-2025 | 08-04-2025 | 08-20-2025 | Class II | 74,088 containers | 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. | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Ongoing |
| D-0586-2025 | 08-04-2025 | 08-20-2025 | Class II | 23,100 containers | 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00. | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0264-7750 | Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7750 | Lactated Ringers | Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7800 | Sodium Chloride | | | | B. Braun Medical Inc. | |
| 0264-7800 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7800 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
| 0264-7802 | Sodium Chloride | Sodium Chloride | Injection, Solution | Intravenous | B. Braun Medical Inc. | Human Prescription Drug |
