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Duloxetine Recalls

What is Duloxetine?

Duloxetine is an antidepressant medication that is used to treat major depressive disorder and chronic pain conditions, such as fibromyalgia and diabetic peripheral neuropathy. It is sold under the brand name Cymbalta.

Why is Duloxetine Being Recalled?

In 2023, several manufacturers of generic duloxetine have issued recalls due to the presence of an impurity known as N-methylacetamide (NMA). NMA is a probable human carcinogen (cancer-causing agent) and has been found in unacceptable levels in some batches of duloxetine.

Affected Products:

  • Aurobindo Pharma USA, Inc.
  • Duloxetine HCl Delayed-Release Capsules, 20 mg and 60 mg
  • Duloxetine HCl Extended-Release Capsules, 20 mg, 30 mg, and 60 mg
  • Lupin Pharmaceuticals, Inc.
  • Duloxetine Delayed-Release Capsules, 20 mg, 30 mg, and 60 mg
  • Duloxetine HCl Extended-Release Capsules, 20 mg, 30 mg, and 60 mg
  • Prasco Laboratories
  • Duloxetine HCl Delayed-Release Capsules, 20 mg, 30 mg, and 60 mg
  • Teva Pharmaceuticals USA, Inc.
  • Duloxetine HCl Delayed-Release Capsules, 20 mg, 30 mg, and 60 mg
  • Duloxetine HCl Extended-Release Capsules, 20 mg, 30 mg, and 60 mg

Health Risks:

The risk of cancer from exposure to the NMA impurity in duloxetine is considered to be low. However, individuals who have taken affected products over a long period or at high doses may have an increased risk.

Symptoms of Exposure:

There are no specific symptoms associated with exposure to NMA.

What to Do if You Have Affected Duloxetine:

If you are taking duloxetine from one of the affected manufacturers, you should contact your doctor immediately. Your doctor will advise you on the best course of action, which may include discontinuing the medication.

Do Not Stop Taking Duloxetine Abruptly:

Stopping duloxetine suddenly can lead to serious side effects, such as nausea, vomiting, diarrhea, insomnia, and anxiety. It is important to follow your doctor’s instructions when discontinuing the medication.

Stay Informed:

The FDA is continuing to monitor the duloxetine recall situation and will provide updates as they become available. You can sign up for email updates from the FDA at: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sign-email-subscription-recalls-safety-alerts

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