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Drug FDA Class II Ongoing cGMP deviation

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

Glenmark Pharmaceuticals Inc., USA Published Dec 11, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Hazards

N-nitroso-Desmethyl-Diltiazem · primary

Affected products (1)

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

DILTIAZEM HYDROCHLORIDE · 12,864 bottles

NDC: 68462-562, 68462-850, 68462-851, 68462-850-01, 68462-851-01, 68462-562-01
Code info: Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 1, 2024
  2. Published
    Dec 11, 2024
Recall number
D-0094-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.