Glenmark recalls 90mg extended-release diltiazem capsules due to potential impurity levels exceeding FDA safety limits. Affected lots manufactured in India with specific expiration dates. Consumers should contact the manufacturer for details.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark is recalling 90mg extended-release diltiazem capsules because they contain an impurity that exceeds FDA safety limits. This could pose a health risk if taken as directed. The recall affects specific production lots with known expiration dates.
The capsules contain N-nitroso-Desmethyl-Diltiazem impurities above FDA-recommended levels. This impurity could potentially cause health issues when taken as directed, though the exact risk level isn't specified in the recall notice.
Prescription medication users who have the specific lot numbers listed in the recall. Patients taking diltiazem for blood pressure or other conditions are most at risk.
Check for the product name 'Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules' with lot numbers 17222452 (expiring 11/30/2024) or 17230607 (expiring 02/28/2025).
Identify the lot number and expiration date on the product packaging to confirm if it matches the recalled lots.
The recall is due to the presence of N-nitroso-Desmethyl-Diltiazem impurities above FDA-recommended safety limits.
Check the product details to see if it matches the recalled lots. If it does, contact Glenmark Pharmaceuticals for further instructions.
The recall indicates potential health risks due to impurities exceeding safety limits, but the exact risk level isn't specified in the notice.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0094-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0094-2025 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
