Class II U.S. Food and Drug Administration

Heritage Pharmaceuticals Inc Desipramine Hydrochloride Tablets, USP, 100 mg recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible

Recall published 12 months ago

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

The hazard: Potency, impurity or stability failure

An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

What the notice says: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0111-2026
Published
November 5, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Heritage Pharmaceuticals Inc
Product type
Prescription & OTC drugs
Units affected
5,882 bottles.
Distribution
Nationwide
Made in
United States
Lot / code info
Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026

Products covered by this recall

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.

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 18035574
  • 31
  • 2025 Lot

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 10
  • 31
  • 2025 Lot
  • 08
  • 2026 — 5
  • 882 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 23155-582-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 mg
  • 100 count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Heritage Pharmaceuticals Inc — An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  3. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  4. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Heritage Pharmaceuticals Inc — 1 Tower Center Blvd Ste 1700, East Brunswick, NJ, 08816-1145

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Heritage Pharmaceuticals Inc prescription & otc drugs recalled?

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 18035574, 31, 2025 Lot; best-by date 10 or 31. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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