Heritage Pharmaceuticals recalls 100mg Desipramine tablets due to N-Nitroso impurity exceeding safe levels. Rx-only medication with specific lot numbers and expiration dates.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals is recalling 100mg Desipramine Hydrochloride tablets that contain an impurity exceeding safe levels. This could pose a health risk if taken as prescribed.
The tablets contain N-Nitroso Desipramine, an impurity that exceeds the permissible acceptable daily intake level. This impurity could potentially cause health issues if taken as directed, though the risk is considered low based on current testing.
Prescription medication users who have the specific 100-count bottle with lot numbers 18035574 (expiring 10/31/2025) or 18036758 (expiring 8/31/2026). Patients taking this medication for depression or anxiety are most at risk.
Check for the 100mg Desipramine Hydrochloride tablets in a 100-count bottle with lot number 18035574 (expiring 10/31/2025) or 18036758 (expiring 8/31/2026). The product is prescription-only and manufactured by USV in India.
Verify the lot number and expiration date on the bottle to confirm if it's affected.
Talk to your healthcare provider about whether you should stop using the medication and get alternative treatment.
The recall is due to an impurity exceeding safe levels, but the medication is still considered safe for use if taken as prescribed by a doctor. Patients should consult their healthcare provider.
Check the lot number and expiration date on the bottle. If it matches the recalled lots, contact your doctor for guidance on safe alternatives.
The recall record does not mention a replacement program. Contact your doctor for alternative treatment options.
We’ve drafted a message you can send Heritage Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0111-2026 — Heritage Pharmaceuticals Heritage Pharmaceuticals Hello, I own a Heritage Pharmaceuticals that is covered by recall D-0111-2026 from Heritage 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.
