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Class I · Most seriousRecall completed

Vancomycin Hydrochloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
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

Superpotent Drug: Due to overfilling of drug powder

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 byAmneal Pharmaceuticals NY LLC
Brand nameVANCOMYCIN HYDROCHLORIDE
Generic nameVANCOMYCIN HYDROCHLORIDE
Active ingredient(s)VANCOMYCIN HYDROCHLORIDE
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC69238-2261-3
Show the full FDA record
Full product labelVancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Recalling firmAmneal Pharmaceuticals of New York, LLC
DistributionNationwide in the USA.
Quantity821 bottles
Recall initiated2024-03-21
Report date2024-04-24
Recall completed2025-07-21
Recall numberD-0442-2024
ClassificationClass I
FDA statusTerminated
Origin on fileBrookhaven NY United States

Related

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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.