Lactated Ringer's Injection USP recall
FDA recall D-0585-2025 · initiated Aug 4, 2025
B BRAUN MEDICAL INC recalled Lactated Ringer's Injection USP in Aug 2025 — an FDA Class II recall (D-0585-2025) because Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 74,088 containers
Details
- 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.
- Recalling company
- B Braun Medical
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Aug 4, 2025
- FDA report date
- Aug 20, 2025
Frequently asked
- Was Lactated Ringer's Injection USP recalled?
- B BRAUN MEDICAL INC recalled Lactated Ringer's Injection USP in Aug 2025 — an FDA Class II recall (D-0585-2025) because Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lactated Ringer's Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0585-2025 was: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
- Is a recalled Lactated Ringer's Injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lactated Ringer's Injection USP are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0585-2025.