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Recall Observatory FDA recall evidence

Drug product

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

D-0054-2025

October 23, 2024

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 95610
Status
Terminated
Classification
Class II
Quantity
357,414 bottles
Official record key
drug-enforcement:D-0054-2025

Official wording

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

Code information: 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

Distribution pattern: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations