Class II U.S. Food and Drug Administration

Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA

Recall published 11 months ago

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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; presence of N-nitroso-duloxetine impurity above the FDA recommended 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-0216-2026
Published
December 10, 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
7389 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.

Products covered by this recall

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

Check your product

The notice names 8 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.

  • 240534C
  • 2027

Best-by / use-by date

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

  • 01
  • 2027
  • 04
  • 2027. — 7389 bottles

NDC number

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

  • 51991-748-10

Package size

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

  • 60 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. — 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. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

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: 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; presence of N-nitroso-duloxetine impurity above the FDA recommended limit CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 240534C, 2027; best-by date 01 or 2027. 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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