Glenmark Pharmaceuticals recalls 120mg extended-release diltiazem capsules due to potential presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA limits. Affected lots manufactured in India with specific expiration dates.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals is recalling 120mg extended-release diltiazem capsules that may contain an impurity above FDA safety limits. This could pose a risk to users taking the medication as prescribed.
The capsules may contain N-nitroso-Desmethyl-Diltiazem impurities at levels above the FDA's recommended safety limit. This impurity could potentially cause health issues when taken as directed.
People prescribed diltiazem hydrochloride extended-release capsules by a doctor in the US. Those with specific lot numbers and expiration dates listed in the recall are most at risk.
Check the product label for the lot number (17222547 or 17230598) and expiration date (November 30, 2024 or February 28, 2025). The product is a 120mg extended-release capsule for twice-daily use.
Look for the lot number (17222547 or 17230598) and expiration date on the bottle.
The capsules may contain N-nitroso-Desmethyl-Diltiazem impurities at levels above the FDA's recommended safety limit.
The recall record does not specify a remedy or action steps for affected products.
Lot numbers 17222547 (expiring November 30, 2024) and 17230598 (expiring February 28, 2025).
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0098-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0098-2025 from Glenmark Pharmaceuticals. 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.
