Class II U.S. Food and Drug Administration

Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 50 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug

Recall published 12 months ago

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

The hazard: Harmful chemical exposure

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

What the notice says: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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-0153-2026
Published
November 12, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Zydus Pharmaceuticals Inc
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
a) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026

Products covered by this recall

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

Check your product

The notice names 25 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.

  • E410157
  • E407176
  • E405845
  • E400943
  • E410156
  • E400942
  • E410158
  • E407128
  • E405846
  • E400944

Best-by / use-by date

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

  • 12
  • 2026
  • 08
  • 06
  • 01
  • 2026 b
  • 2026 c
  • 2026 — N

NDC number

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

  • 16714-850-01
  • 16714-850-02
  • 16714-850-03

Package size

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

  • 50 mg
  • 30 count
  • 90 count
  • 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 Chemical

Zydus Pharmaceuticals Inc — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  3. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  4. Ventilate the room if the product was sprayed or applied there.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: Zydus Pharmaceuticals (USA) Inc — 73 Route 31 N, Pennington, NJ, 08534-3601

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 Zydus Pharmaceuticals Inc prescription & otc drugs recalled?

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code E410157, E407176, E405845; best-by date 12 or 2026. 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?

Stop using the product and keep it away from children and pets.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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