The Recall Desk
ModerateFDA (Drugs)·D-0542-2025·Announced 2025-08-06

Amlodipine Besylate and Benazepril Capsules Recalled for Incorrect Expiration Date Label

Lupin Pharmaceuticals is recalling 7,668 bottles of Amlodipine Besylate and Benazepril Hydrochloride capsules distributed nationwide due to incorrect expiration dates on the label.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a minor labeling error with no reported illnesses or injuries. The hazard is theoretical—potential use of expired medication—rather than actual harm. Per the rubric, minor labeling errors are classified as Score 2 (Moderate).

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Amlodipine Besylate and Benazepril Hydrochloride Capsules USP 2.5 mg/10 mg (Lot GB01616) due to a labeling error. The bottles were released with an incorrect expiration date printed on the label.

The label shows an expiration date of February 28, 2027, but the correct expiration date is January 2027. This discrepancy could lead to patients using the medication beyond its actual shelf life if they rely on the printed expiration date.

The recall affects 7,668 bottles distributed nationwide. Patients should contact their pharmacist or physician if they have this medication to verify the correct expiration date. Healthcare providers and pharmacies should quarantine and remove affected bottles from stock.

The recalled product

Product
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
Brand
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Manufacturer
Lupin Pharmaceuticals Inc.
Hazard
  • incorrect-expiration-date
  • mislabeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot GB01616
  • expiration 2/28/2027

UPCs (1)

  • 0368180459019

Distribution

Distributed nationwide across the United States.