Fresenius Sodium Chloride Injection Recall: Lack of Sterility Assurance
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection in flexible plastic containers nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with a significant risk of harm (in this case, lack of sterility assurance in an intravenous injectable product) meet the Severe (4) threshold.
Plain-English summary
Fresenius Medical Care Holdings, Inc., is recalling 0.9% Sodium Chloride Injection, USP, supplied in flexible plastic containers. The product is distributed nationwide under NDC 49230-300-10 with the brand name Sodium Chloride. The recall affects approximately 3,651,468 containers.
The recall is due to lack of assurance of sterility. Affected batch codes include multiple lots with expiration dates ranging from November 2025 through March 2026. The specific lot numbers are detailed in the product information and include codes such as 24PU06037 through 24PU06055 (exp. 11/30/2025), 24SU06001 through 24SU06057 (exp. 12/31/2025), and additional batches expiring through 03/31/2026.
Patients and healthcare providers should immediately stop using the affected lots and consult with Fresenius Medical Care at 1-800-323-5188 for guidance on replacement product or disposal. Healthcare facilities should check their inventory against the provided lot numbers and expiration dates.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Drug — Intravenous Injectable
- Affected units
- 3,651,468
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 24PU06037
- 24PU06038
- 24PU06040
- 24PU06041
- 24PU06042
- 24PU06043
- 24PU06044
- 24PU06045
- 24PU0646
- 24PU06047
- 24PU06048
- 24PU06049
- 24PU06050
- 24PU06052
- 24PU06053
- 24PU06054 & 24PU06055
- Exp Date 11/30/2025
- 24SU06001
- 24SU06002
- 24SU06003
Distribution
Distributed nationwide across the United States.
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