FDA recall D-0052-2025

Product

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2024-10-23

Report date

2024-11-27

Termination date

2026-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2025