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FDAFDA · Food and drugs·Recall number D-0054-2025

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

Published November 27, 2024 · Recall initiated: October 23, 2024

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
RAMIPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Distributor
Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
UPC
0368180591092
Lot
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
Risk classification
Class II
Area (FDA)
drug
Country
United States

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