RecallRadar

FDA Drug recall D-0052-2025

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,…

On 2024-11-27 the FDA classified a Class II recall of 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,… by Lupin Pharmaceuticals, citing CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0052-2025
ClassificationClass II
Statusterminated
Initiated2024-10-23
Published2024-11-27
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

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

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

Identifiers

ndc68180-589-09
ndc68180-589-10
ndc68180-589-01
ndc68180-589-02
ndc68180-590-09
ndc68180-590-10
ndc68180-590-01
ndc68180-590-02
ndc68180-591-09
ndc68180-591-10
ndc68180-591-02
ndc68180-591-01
ndc68180-588-01
ndc68180-588-02
ndc68180-588-09
code_info
a) NDC 68180-589-09; Lots G326781, exp. date 30-Sep-25, GA04468, exp. date 31-May-25 b) NDC 68180-589-01; Lots G32…a) NDC 68180-589-09; Lots G326781, exp. date 30-Sep-25, GA04468, exp. date 31-May-25 b) NDC 68180-589-01; Lots G326763, exp. date 30-Sep-25, GA03041, exp. date 31-Mar-26, GA03725, exp. date 30-Apr-26, GA04402, exp. date 31-May-26, c) NDC 68180-589-02; Lots G326782, exp. date 30-Sep-25, GA04462, exp. date 31-May-26

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0052-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.