Heritage Pharmaceuticals recalls 50mg Desipramine tablets due to N-Nitroso impurity exceeding safe levels. Rx-only medication with specific NDC number. No remedy stated in recall notice.
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals is recalling 50mg Desipramine Hydrochloride tablets (NDC 23155-580-01) because they contain an impurity that could exceed safe levels. This is a prescription-only medication that may pose health risks if taken without proper medical supervision.
The tablets contain N-Nitroso Desipramine, an impurity that exceeds the permissible acceptable daily intake level. This could potentially cause health issues if the medication is taken as directed without proper medical supervision.
Prescription patients who have the specific 50mg Desipramine tablets with NDC 23155-580-01. Patients taking this medication for depression or other conditions should be cautious as the impurity could affect safety.
Check for the 50mg Desipramine Hydrochloride Tablets, USP, 100-count bottle with NDC code 23155-580-01. This medication is prescription-only and manufactured by USV Private Limited in Daman, India.
Verify the product label matches the recalled 50mg Desipramine Hydrochloride Tablets, USP, 100-count bottle with NDC 23155-580-01.
The recall states the tablets contain an impurity exceeding safe levels, but the manufacturer has not provided specific safety guidance for current use.
The recall notice does not specify any action steps for affected patients.
Check the product label for the NDC code 23155-580-01 on the 50mg Desipramine Hydrochloride Tablets, USP, 100-count bottle.
We’ve drafted a message you can send Heritage Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0109-2026 — Heritage Pharmaceuticals Heritage Pharmaceuticals Hello, I own a Heritage Pharmaceuticals that is covered by recall D-0109-2026 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.
