Heritage Pharmaceuticals Desipramine Tablets Recall: N-Nitroso Impurity Risk
Heritage Pharmaceuticals recalls 25mg Desipramine tablets with N-Nitroso impurity exceeding safe levels. Rx-only medication may pose health risks if taken.
Recall notice
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Contact the company
What happened, in plain English
Heritage Pharmaceuticals is recalling 25mg Desipramine Hydrochloride tablets that contain an impurity (N-Nitroso Desipramine) exceeding safe levels. This could pose health risks if taken as prescribed. Read more at govinfonow.com/recall/31755-heritage-pharmaceuticals-desipramine-tablets-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31755-heritage-pharmaceuticals-desipramine-tablets-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0108-2026
Cite this page
“Heritage Pharmaceuticals Desipramine Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31755-heritage-pharmaceuticals-desipramine-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0108-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0108-2026%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitroso Desipramine impurities that exceed the permissible acceptable daily intake level. This impurity could potentially cause health risks when taken as prescribed.
Who’s affected
Prescription users of Desipramine Hydrochloride tablets (25mg, 100-count) manufactured by USV in India for Avet Pharmaceuticals. Those with a prescription for this medication are most at risk.
How to tell if you have this one
Check for the product name 'Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle' with NDC 23155-579-01. The lot numbers are 18035876 (expiring 12/31/2025) and 18036909 (expiring 09/30/2026).
- Brand
Heritage Pharmaceuticals- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
U.S. Nationwide.- NDC
23155-578-01, 23155-579-01, 23155-580-01, 23155-581-01, 23155-582-01, 23155-583-25
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0107-2026 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.; Lot#: 18036908, Exp. Date: 09/30/2026 | 6,979 bottles. |
| D-0108-2026 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.; Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026 | 8,754 bottles. |
| D-0109-2026 | 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.; Lot#:18036713, Exp Date: 08/31/2026 | 5880 bottles. |
| D-0110-2026 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.; Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027 | 2,418 bottles. |
| D-0111-2026 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.; Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026 | 5,882 bottles. |
| D-0112-2026 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.; Lot#: 18035739, Exp. Date: 11/30/2025 | 3,750 bottles. |
What to do — step by step
Check Product Details
Identify the product by checking the NDC code 23155-579-01 and lot numbers 18035876 or 18036909.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0108-2026 (October 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0108-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.