Class II U.S. Food and Drug Administration

Asclemed USA Inc. Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx recall: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity

Recall published 5 months ago

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, 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; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, 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-0555-2026
Published
June 10, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Asclemed USA Inc.
Product type
Prescription & OTC drugs
Units affected
50 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026

Products covered by this recall

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

Check your product

The notice names 7 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.

  • 050725G-30

Best-by / use-by date

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

  • 06
  • 30
  • 2026 — 50 bottles

NDC number

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

  • 76420-634-30

Package size

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

  • 30 mg
  • 30 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

Asclemed USA 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: Asclemed USA Inc. — 379 Van Ness Ave Ste 1403, Torrance, CA, 90501-7211

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 Asclemed USA Inc. prescription & otc drugs recalled?

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, 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 050725G-30; best-by date 06 or 30. 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.

Related recalls