Breckenridge Pharmaceutical recalls nearly 360,000 Cymbalta bottles

Breckenridge Pharmaceutical recalled nearly 360,000 Cymbalta bottles on June 4 over nitrosamines, including 30-mg and 60-mg capsules.

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Breckenridge Pharmaceutical recalls nearly 360,000 Cymbalta bottles

Breckenridge Pharmaceutical recalled nearly 360,000 bottles of Cymbalta on June 4 after the FDA said the duloxetine capsules contained high levels of nitrosamines. The recall covers delayed-release capsules in 30-mg and 60-mg sizes and reached consumers nationwide.

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Breckenridge Pharmaceutical and Cymbalta

Duloxetine is a generic version of Cymbalta, and the recalled medicine is a prescription drug. The FDA said nitrosamines may increase the risk of cancer, which is why the batch was pulled from distribution.

For people who already have the medication, the practical step is to check the bottle against the recalled 30-mg product details. The affected 30-mg capsules carry lot code 241180C and an expiration date of April 2027.

FDA recall details

The recall applies to both 30-mg and 60-mg delayed-release capsules. Breckenridge Pharmaceutical’s action on June 4 centered on nearly 360,000 bottles, making this a large nationwide withdrawal of a commonly used prescription medication.

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That scale leaves patients with a simple task: compare the label, lot code, and capsule strength before taking another dose. If the bottle matches the recalled 30-mg lot, a pharmacist or doctor can advise on the safest replacement.

What Cymbalta users should do

Experts said not to stop taking the medication without speaking to a medical professional. That advice matters because the recalled drug is still a medicine many patients rely on daily, and the recall does not mean every bottle or strength is affected in the same way.

The immediate question for 60-mg bottles is which lot codes and expiration dates are included. The answer will determine whether a patient needs to set that bottle aside or continue with a different supply after speaking with a medical professional.

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Investigative news reporter specialising in local government, public policy, and social issues. Two-time Regional Press Award winner.