Recalls / Class II
Class IID-0335-2026
Product
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
- Affected lot / code info
- Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C274-000049413, Exp Date: 5-May-26; Lot # C274-000049571, Exp Date: 10-May-26; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fresenius Kabi Compounding, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Dan Rd, N/A, Canton, Massachusetts 02021-2809
Distribution
- Quantity
- 10,548 bags
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2026-02-05
- FDA classified
- 2026-02-13
- Posted by FDA
- 2026-02-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0335-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.