Lactated Ringers's Injection USP recall
FDA recall D-0627-2025 · initiated Aug 18, 2025
B BRAUN MEDICAL INC recalled Lactated Ringers's Injection USP in Aug 2025 — an FDA Class I recall (D-0627-2025) because Presence of Particulate Matter.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 46,032 containers
Details
- Product
- Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
- Recalling company
- B Braun Medical
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Aug 18, 2025
- FDA report date
- Sep 10, 2025
Frequently asked
- Was Lactated Ringers's Injection USP recalled?
- B BRAUN MEDICAL INC recalled Lactated Ringers's Injection USP in Aug 2025 — an FDA Class I recall (D-0627-2025) because Presence of Particulate Matter. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Lactated Ringers's Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0627-2025 was: Presence of Particulate Matter
- Is a recalled Lactated Ringers'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. Most serious — a reasonable probability that use will cause serious harm or death. 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 Ringers's Injection USP are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot #: J4S807, Exp 5/31/2027. 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-0627-2025.