Why it was recalled
Lack of Assurance of Sterility: Potential for flexible container leaks.
Product description
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lot numbers, UPCs & expiration codes
Lot # 1029921, Exp Date: 28 February 2027
Where it was sold
Distributed Nationwide in the USA.
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-0143-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 27, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 509,360 100 mL bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Otsuka ICU Medical LLC
Original FDA data
Every field from FDA enforcement report D-0143-2026, exactly as published.
Show all FDA fields
- City
- Austin
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 97841
- Address
- 3900 Howard Ln
- Code information
- Lot # 1029921, Exp Date: 28 February 2027
- Postal code
- 78728-6515
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0143-2026
- Classification
- Class II
- Recalling firm
- Otsuka ICU Medical LLC
- Product quantity
- 509,360 100 mL bags
- Reason for recall
- Lack of Assurance of Sterility: Potential for flexible container leaks.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Distribution pattern
- Distributed Nationwide in the USA.
- Recall initiation date
- Oct 27, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 30, 2025