Recall: D-0053-2025

Class II - Potentially Harmful

Class IIClassification

2024-10-23Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Reason

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.