Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0
Summary
The FDA issued a Class I for Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, I by B BRAUN MEDICAL INC. Reason: Presence of Particulate Matter..
Details
Source
Drug Recall
External ID
D-0540-2026
Action Date
2026-05-13
Status
Ongoing
Category
drug
Product Description
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Lot/Code Info: Lot #:J4P756, J4S843, Exp 5/31/2027
Quantity Affected: 95,412 containers
Reason for Recall
Presence of Particulate Matter.
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-28
Company
Allentown, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 68 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
B BRAUN MEDICAL INC has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B BRAUN MEDICAL INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B BRAUN MEDICAL INC have FDA actions?
B BRAUN MEDICAL INC has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0540-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22