← FDA ENFORCEMENT
D-0054-2025Class II

Lupin Pharmaceuticals Inc.

Recalling firm
Lupin Pharmaceuticals Inc.
Product type
Drug
Status
Terminated
Report date
2024-11-27
Distribution
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Firm state
MD
Product quantity
357,414 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Product description

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Code / lot info

a) NDC 68180-591-09; Lots G327086, exp. date 30-Sep-25 GA01065, exp. date 31-Dec-25, b) NDC 68180-591-01 Lots G325033, G324987, exp. date 31-Jul-25, G325110, GA00956, GA01066, GA01126, exp. date 31-Dec-25, GA03299, GA03288, GA03287, exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919, exp. date 31-Jul-26 G327131, exp. date 30-Sep-25

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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.