RecallRadar

FDA Drug recall D-0472-2024

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glen…

On 2024-05-01 the FDA classified a Class II recall of Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glen… by Glenmark Pharmaceuticals Usa, citing failed Dissolution Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0472-2024
ClassificationClass II
Statusongoing
Initiated2024-04-17
Published2024-05-01
Last updated2026-09-13 11:52 UTC
CompanyGlenmark Pharmaceuticals Usa
DistributionUS

Product

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.

Reason

Failed Dissolution Specifications

Identifiers

ndc68462-850-01
ndc68462-851-01
ndc68462-562-01
code_infoLot #: 17221312, Exp. 5/31/2024

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0472-2024%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.