Drug FDA Class II Ongoing cGMP deviation
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Heritage Pharmaceuticals Inc Published Nov 5, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Heritage Pharmaceuticals Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Hazards
N-Nitroso Desipramine · primary
Affected products (1)
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
DESIPRAMINE HYDROCHLORIDE · 5880 bottles.
NDC: 23155-578, 23155-579, 23155-580, 23155-581, 23155-582, 23155-583, 23155-578-01, 23155-579-01, 23155-580-01, 23155-581-01, 23155-582-01, 23155-583-25
Code info: Lot#:18036713, Exp Date: 08/31/2026
Affected areas
Nationwide
Timeline
- InitiatedOct 6, 2025
- PublishedNov 5, 2025
- Recall number
- D-0109-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.