← FDA ENFORCEMENT
D-0542-2025Class II

Lupin Pharmaceuticals Inc.

Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Completed
Report date
2025-08-06
Distribution
Nationwide in the US
Firm state
FL
Product quantity
7668 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Product description

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.

Code / lot info

Lot GB01616, expiration 2/28/2027

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.