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FDAFDA · Food and drugs·Recall number D-0053-2025

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) 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 68180-590-09; Lots G326928, exp. date 30-Sep-25, GA00964, exp. date 31-Dec-25, b) NDC 68180-590-01, Lots G326897, G326929, exp. date 30-Sep-25, GA00854, GA00933, GA00954, exp. date 31-Dec-25, c) NDC 68180-590-02, Lot GA00955, exp. date 31-Dec-25
Risk classification
Class II
Area (FDA)
drug
Country
United States

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