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Class III · Lower riskRecall completed

Cyanocobalamin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLots: CCC210004, Exp 09/2022; CCC210005, CCC210006, CCC210007, Exp 11/2022; CCC210010, CCC210011, Exp 04/2023.
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Subpotent Drug: Out of Specification results for Assay

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAuroMedics Pharma LLC
Brand nameCYANOCOBALAMIN
Generic nameCYANOCOBALAMIN
Active ingredient(s)CYANOCOBALAMIN
Distributed by / forAurobindo Pharma USA Inc.
NDC55150-364-01
Show the full FDA record
Full product labelCyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Recalling firmAurobindo Pharma USA Inc.
DistributionNationwide in the USA.
Quantity433,809 vials
Recall initiated2022-04-05
Report date2022-04-20
Recall completed2024-06-27
Recall numberD-0766-2022
ClassificationClass III
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.