Desipramine Hydrochloride Tablets, USP, 25 mg
Recalled by Heritage Pharmaceuticals Inc
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Heritage Pharmaceuticals Inc has recalled Desipramine Hydrochloride Tablets, USP, 25 mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on November 5, 2025 and was initiated on October 6, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Desipramine Hydrochloride Tablets, USP, 25 mg, with approximately 8,754 bottles. affected. The company behind the recall is Heritage Pharmaceuticals Inc, based in East Brunswick, NJ. The FDA describes the product as: “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.”
Why was Desipramine Hydrochloride Tablets, USP, 25 mg recalled?
According to the FDA, the stated reason for the recall is: “CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).
CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.
What should you do?
If you think you may have bought Desipramine Hydrochloride Tablets, USP, 25 mg, compare it against the product description and identifying codes (Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Heritage Pharmaceuticals Inc or your local health authority.
About this recall
This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Desipramine Hydrochloride Tablets, USP, 25 mg. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: U.S. Nationwide..
What manufacturing quality issue (CGMP) actually means
CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.
In this case, the concern applies specifically to Desipramine Hydrochloride Tablets, USP, 25 mg from Heritage Pharmaceuticals Inc — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot#: 18035876, Exp Date: 12/31/2025 Lot#: 18036909, Exp Date: 09/30/2026
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- November 5, 2025
- Recall started
- October 6, 2025
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Desipramine Hydrochloride Tablets, USP, 25 mg recalled?+
According to the FDA: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Desipramine Hydrochloride Tablets, USP, 25 mg?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0108-2026. Information last synced from the FDA on July 6, 2026.