Class IITerminated

Ramipril Capsules USP 5 mg recall

FDA recall D-0053-2025 · initiated Oct 23, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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
Recalling company: Lupin Pharms
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Initiated: Oct 23, 2024
FDA report date: Nov 27, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0053-2025 ↗

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