Lactated Ringer's Injection USP recall
FDA recall D-0431-2024 · initiated Mar 22, 2024
B. Braun Medical Inc recalled Lactated Ringer's Injection USP in Mar 2024 — an FDA Class II recall (D-0431-2024) because Lack of assurance of sterility: bags have the potential to leak..
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of sterility: bags have the potential to leak..
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: 7,800 bags
Details
- Product
- Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
- Recalling company
- B Braun Medical
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 22, 2024
- FDA report date
- Apr 10, 2024
Frequently asked
- Was Lactated Ringer's Injection USP recalled?
- B. Braun Medical Inc recalled Lactated Ringer's Injection USP in Mar 2024 — an FDA Class II recall (D-0431-2024) because Lack of assurance of sterility: bags have the potential to leak.. 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-0431-2024 was: Lack of assurance of sterility: bags have the potential to leak..
- 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 USA. The recall covers these lots — Lot #: J3N023, Exp: 31 March 2026. 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-0431-2024.