0.9% SODIUM CHLORIDE Injection recall
FDA recall D-0143-2026 · initiated Oct 27, 2025
Otsuka ICU Medical LLC recalled 0.9% SODIUM CHLORIDE Injection in Oct 2025 — an FDA Class II recall (D-0143-2026) because Lack of Assurance of Sterility: Potential for flexible container leaks.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Potential for flexible container leaks.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
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: 509,360 100 mL bags
Details
- Product
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Recalling company
- Otsuka ICU Medical LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Oct 27, 2025
- FDA report date
- Nov 5, 2025
Frequently asked
- Was 0.9% SODIUM CHLORIDE Injection recalled?
- Otsuka ICU Medical LLC recalled 0.9% SODIUM CHLORIDE Injection in Oct 2025 — an FDA Class II recall (D-0143-2026) because Lack of Assurance of Sterility: Potential for flexible container leaks. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was 0.9% SODIUM CHLORIDE Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0143-2026 was: Lack of Assurance of Sterility: Potential for flexible container leaks.
- Is a recalled 0.9% SODIUM CHLORIDE Injection 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 0.9% SODIUM CHLORIDE Injection are affected?
- Distributed: Distributed Nationwide in the USA.. The recall covers these lots — Lot # 1029921, Exp Date: 28 February 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-0143-2026.