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Class III · Lower riskRecall completed

Benazepril Hydrochloride

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

Does this affect you?
Check your lot numberLot # BB02619A, exp. date 04/2021
Where it was soldProduct was distributed to 13 major distributors throughout the United States who may have further distribute the product.
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

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

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 LLC
Brand nameBENAZEPRIL HYDROCHLORIDE
Generic nameBENAZEPRIL HYDROCHLORIDE
Active ingredient(s)BENAZEPRIL HYDROCHLORIDE
Distributed by / forAmneal Pharmaceuticals, Bridgewater, NJ
NDC65162-754-10
Show the full FDA record
Full product labelBenazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Recalling firmAmneal Pharmaceuticals, Inc.
DistributionProduct was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Quantity9,720 100 count bottles
Recall initiated2019-09-24
Report date2019-10-16
Recall completed2021-03-04
Recall numberD-0134-2020
ClassificationClass III
FDA statusTerminated
Origin on fileBrookhaven NY 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.