Glenmark Pharmaceuticals recalls 120mg Diltiazem Hydrochloride Extended-Release Capsules due to potential presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA limits. This may pose a risk of serious injury. Check NDC 68462-562-01 and lot numbers for affected batches.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark is recalling 120mg Diltiazem Hydrochloride Extended-Release Capsules because they contain an impurity that could be harmful. This recall affects prescription-only capsules with specific lot numbers and expiration dates. The impurity may cause serious health risks if taken.
The capsules contain N-nitroso-Desmethyl-Diltiazem impurity levels above FDA's interim safety limits. This impurity could potentially cause serious health effects when taken as directed. The exact risk level isn't clearly stated in the recall notice.
Prescription patients who own the recalled Diltiazem capsules with specific lot numbers and expiration dates. Those taking the medication for heart conditions are most at risk.
Check for NDC 68462-562-01 on the product label. Look for lot numbers: 17222470, 17230680, 17222547 (expiring 11/30/2024), 17230304 (expiring 12/31/2024), and 17230598 (expiring 02/2025).
Look for NDC 68462-562-01 and specific lot numbers listed in the recall notice.
The recall states there's a potential risk from impurities above FDA limits, but the exact health risk isn't clearly specified in the notice.
Check the product label for NDC 68462-562-01 and lot numbers: 17222470, 17230680, 17222547 (expiring 11/30/2024), 17230304 (expiring 12/31/2024), or 17230598 (expiring 02/2025).
The recall notice doesn't specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0095-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0095-2025 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.
