Data Foundry

Drug recalls 2025

Carvedilol Tablets USP 12 — Class II drug recall D-0450-2025

Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-06-04, distributed nationwide. CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Recall numberD-0450-2025
Product typeDrug
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States
Recall initiated2025-02-28
Classified2025-05-28
Reported by FDA2025-06-04
DistributedNationwide (US)
Quantity84,048 bottles
Reason classescgmp, specification failure
NDC68462-0162, 68462-0162-01, 68462-0162-05, 68462-0162-10, 68462-0162-18, 68462-0162-60, 68462-0163, 68462-0163-01, 68462-0163-05, 68462-0163-10, 68462-0163-18, 68462-0163-60, 68462-0164, 68462-0164-01, 68462-0164-05, 68462-0164-10, 68462-0164-18, 68462-0164-60, 68462-0165, 68462-0165-01, 68462-0165-05, 68462-0165-10, 68462-0165-18, 68462-0165-60
Lot numbers19231899, 19231922, 19231927, 19231967, 19231979, 19232226, 19232234, 19232265, 1923227, 19232758, 19232759, 19232762, 19232788, APR-25, JUN-25, MAY-25

Product

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

Reason for recall

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0450-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.