Class II U.S. Food and Drug Administration

Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP, 30 mg, 1 recall: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim

Recall published 1+ years ago

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

The hazard: Potency, impurity or stability failure

The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

What the notice says: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

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-0621-2025
Published
September 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Breckenridge Pharmaceutical, Inc.
Product type
Prescription & OTC drugs
Units affected
3,591 bottles
Distribution
Arizona, Indiana, New Jersey
Made in
United States
Lot / code info
Lot 240927C, Exp 04/30/2027

Products covered by this recall

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10

Check your product

The notice names 11 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.

  • 240927C
  • Exp 04
  • 30
  • 2027 — 3
  • 591 bottles

Best-by / use-by date

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

  • 04
  • 30
  • 2027 — 3
  • 591 bottles

NDC number

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

  • 82009-030-10

Package size

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

  • 30 mg

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

Breckenridge Pharmaceutical, Inc. — The recall concerns the strength or purity of the medicine rather than contamination of it, which changes what you should do about a dose you have already taken.

  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.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Breckenridge Pharmaceutical, Inc. — 200 Connell Dr Ste 4200, Berkeley Heights, NJ, 07922-2805

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 Breckenridge Pharmaceutical, Inc. prescription & otc drugs recalled?

CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 240927C, Exp 04, 30; best-by date 04 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?

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

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Which states were affected?

The notice lists Arizona, Indiana, New Jersey.

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