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Class I: serious health riskOngoing

B Braun Medical Lactated Ringers's Injection Recall

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B

B BRAUN MEDICAL INC · Allentown, PA

Risk level
Class I
Reported by FDA
Sep 10, 2025
Recall ID
D-0627-2025
Check your lot numberHow we source this data

Summary

B Braun Medical recalled Lactated Ringers's Injection starting Aug 18, 2025. The FDA classified it as Class I (serious health risk) and published enforcement report D-0627-2025 on Sep 10, 2025. Reason: Presence of Particulate Matter. Status: Ongoing.

Why it was recalled

Presence of Particulate Matter

Product description

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

Lot numbers, UPCs & expiration codes

Lot #: J4S807, Exp 5/31/2027

Where it was sold

U.S.A. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0627-2025
Classification
Class I
Status
Ongoing
Recall initiated
Aug 18, 2025
FDA report date
Sep 10, 2025
Quantity
46,032 containers
Recall type
Voluntary: Firm initiated
Recalling firm
B BRAUN MEDICAL INC

Original FDA data

Every field from FDA enforcement report D-0627-2025, exactly as published.

Show all FDA fields
City
Allentown
State
PA
Status
Ongoing
Country
United States
Event ID
97433
Address
861 Marcon Blvd
Code information
Lot #: J4S807, Exp 5/31/2027
Postal code
18109-9577
Report date
Sep 10, 2025
Product type
Drugs
Recall number
D-0627-2025
Classification
Class I
Recalling firm
B BRAUN MEDICAL INC
Product quantity
46,032 containers
Reason for recall
Presence of Particulate Matter
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Aug 18, 2025
Initial firm notification
Letter
Center classification date
Sep 10, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0627-2025, published Sep 10, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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