Recalls / Class I
Class ID-0627-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
- Brand name
- Lactated Ringers
- Generic name
- Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride
- Active ingredients
- Calcium Chloride, Potassium Chloride, Sodium Chloride, Sodium Lactate
- Route
- Intravenous
- NDC
- 0264-7750
- FDA application
- NDA019632
- Affected lot / code info
- Lot #: J4S807, Exp 5/31/2027
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- B BRAUN MEDICAL INC
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 861 Marcon Blvd, N/A, Allentown, Pennsylvania 18109-9577
Distribution
- Quantity
- 46,032 containers
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-08-18
- FDA classified
- 2025-09-10
- Posted by FDA
- 2025-09-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0627-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.