In the agency's Nov 4, 2026 enforcement report · Ongoing
Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY,…
American Regent, Inc.
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 5 Ramsay Rd · Shirley, NY · 11967-4701
Is this the product you have?
- Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY, 11967, NDC 0517-0031-25, (Vial
- NDC0517-0031-01)
- Lot codes and dates
Lot #: 24394Exp. Date October 312026
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate matter: Identified as glass
The agency has not ranked the risk yet — treat the notice as a caution.
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