FDA Issues Duloxetine Recall: What Patients Need to Know

The generic drug duloxetine, an antidepressant, has been recalled. Duloxetine is also sold under the brand name Cymbalta. It is used to treat depression, anxiety, chronic pain, neuropathic pain, and fibromyalgia. Read more about the recent recalls of this popular antidepressant.

Duloxetine Recall (Breckenridge Pharmaceuticals and Rising Pharmaceuticals)

On October 10, 2024, the U.S. Food and Drug Administration (FDA) announced a voluntary manufacturer-initiated duloxetine recall, initiated by Breckenridge Pharmaceuticals. This was for more than 7,000 bottles of duloxetine due to unacceptable levels of a possible cancerous chemical. In addition, the November 19th, 2024 recall by Rising Pharmaceuticals involved 233,003 bottles of 60 mg duloxetine capsules. These recalls were prompted by the detection of a nitrosamine impurity in the medication.

Affected Products and Lot Numbers of the Cymbalta Recall

Breckenridge Pharmaceutical Recall

Product Recalled: Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 500-count bottles.

Lot Number: 220128

Expiration Date: 12/2024

Product Quantity Recalled: 7,107 bottles

Type of Recall: a class II recall indicates that the drug may cause temporary or reversible adverse health consequences, and the likelihood of serious health risks is low. 

Manufactured By: Towa Pharmaceutical

Rising Pharmaceuticals Recall

Product Recalled: Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only

Lot Number (Expiration Date): 

• 30-count bottles: DT6023059A, DT6023060A, DT6023065A, DT6023069A and DT6023070A (January 2025); DT6023080A (February 2025); DT6023093A (March 2025); DTC24012A (December 2025)

• 90-count bottles: DT6023108A with an expiration date of April 2025; DTC23201A with an expiration date Aug 2025

• 1000-count bottles: DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A and DT6022173A (November 2024); DT6023009A, DT6023007A, DT6023008A, DT6023011A and DT6023034B (December 2024); DT6023067C (January 2025); DT6023114A (April 2025); DTC23243A (October 2025); DTC24040A (December 2025)

Product Quantity Recalled: 223,003 bottles

Type of Recall: a class II recall indicates that the drug may cause temporary or reversible adverse health consequences, and the likelihood of serious health risks is low. 

Manufactured By: Rising Pharmaceuticals

Guidelines for Patients Taking Duloxetine

The FDA advises that if you are affected by the duloxetine recall and worried about cancer risk, talk to your healthcare provider or pharmacist. Your pharmacist may be able to dispense the same medication from an unaffected manufacturing lot that has not been recalled.

The FDA says patients taking duloxetine or other prescription medications with potential nitrosamine impurities should not stop treatment without consulting their healthcare providers. Suddenly discontinuing duloxetine can lead to withdrawal symptoms. 

Talk to your health care professional about any concerns and alternative treatment options if you do not want to take drugs such as duloxetine that can potentially contain nitrosamines.

Guidelines for Healthcare Professionals  

Recommendations for Patient Communication  

The FDA recommends healthcare providers educate patients about the reasons for the recall of duloxetine. The goal is to help patients understand the implications of a Class II recall and address any apprehensions related to the duloxetine recall.

Alternatives and Adjustments in Prescriptions  

The FDA recommends healthcare providers discuss alternatives to duloxetine with their patients if their medication was affected by the recall. Treatment options may include medications that do not have potential nitrosamine impurities if available and clinically appropriate.

Reason for the Duloxetine Recall  

Understanding Safety Concerns  

The duloxetine recalls were based on the following concerns:

• The U.S. Food and Drug Administration (FDA) has been investigating the presence of impurities called nitrosamines that are found in the antidepressant duloxetine and certain other medications such as oral anticoagulants, muscle relaxants, and the diabetes drug metformin.

• Taking duloxetine containing nitrosamines above the acceptable daily intake limits over extended periods (several years) may increase the risk of cancer. Short-term exposure is unlikely to pose significant health risks.

• Nitrosamine impurities may enter the drug though factors such as the drug’s manufacturing process, chemical reacitons, or packaging conditions.

• Everyone can expect nitrosamine exposure to some degree because these chemicals are commonly found in water and foods such as grilled and cured meats, vegetables, and dairy products. 

• The U.S. FDA and other regulatory authorities worldwide have set acceptable daily intake limits for nitrosamines. If drugs contain nitrosamines levels above these limits, the FDA recommendation is for the manufacturer to voluntarily recall the drugs due to a potential increased risk of cancer.

• The recommended acceptable intake limit for N-nitroso-duloxetine in duloxetine is 100 nanograms per day (ng/day).

Regulatory Actions and Compliance Steps for Drug Manufacturers

• Pharmaceutical companies are responsible for developing manufacturing processes to prevent unacceptable nitrosamine drug substance-related impurities (NDSRI) and suitable ways to detect these impurities. 

• The FDA has published effective testing methods to detect nitrosamines in drugs.

• In addition, the FDA and the international scientific community have set internationally recognized acceptable daily intake limits for nitrosamines. 

• The FDA recommendation is that drugs be recalled voluntarily by the manufacturer if these acceptable levels are exceeded and the drug is not appropriate for distribution to consumers.

Understanding Duloxetine Safety

Is Cymbalta a High-Risk Medication?  

Cymbalta is a safe and effective medication when used as prescribed. However, it has a black-box warning (the FDA’s strongest warning) for an increased risk of suicidal thoughts and behaviors in people with mental health conditions.

Why Is Duloxetine a Controlled Substance?

Duloxetine is not a controlled substance. However, there have been duloxetine recalls due to a potential risk of cancer because of the presence of nitrosamine compounds above acceptable levels in some lots of the medicines distributed in the U.S.

Is Duloxetine Safe Long Term?  

Yes, duloxetine is safe long-term. There are no known long-term side effects. Many people who are prescribed this antidepressant need to take it for 6 months or longer. If you are feeling better on duloxetine, your healthcare professional may recommend a trial of staying off the medicine. They will tell you how to gradually reduce the dose over a period of several weeks. Do not stop taking duloxetine suddenly without talking to your doctor first.

Who Should Not Take Duloxetine?

Some people should not take duloxetine or take it with caution after discussing the benefits versus risks with their healthcare provider.

• People who have had an allergic reaction to duloxetine or other drugs from the same drug class in the past.

• Those who are taking or have taken within the last 2 weeks the antipsychotic medicine called thioridazine or medications called monoamine oxidase inhibitors (MAOIs) (for example, linezolid (Zyvox), isocarboxazid (Marplan), methylene blue, selegiline (Zelapar, Emsam), phenelzine (Nardil), and tranylcypromine (Parnate)).

• People taking certain other medications that can interact with duloxetine, including:

  • Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin, Advil) and naproxen (Naprosyn, Aleve) 

  • Cimetidine (Tagamet)

  • Proton pump inhibitors such as omeprazole (Prilosec), pantoprazole (Protonix), lansoprazole (Prevacid), and rabeprazole (Aciphex)

  • St. John's wort

  • Tryptophan

• People with a medical history of:

  • Alcohol abuse, street drug abuse, or prescription drug abuse

  • Low sodium

  • Glaucoma 

  • High blood pressure

  • Coronary heart disease 

  • Recent heart attack

  • Seizures

  • Bleeding problems

  • Gastrointestinal problems such as slowed stomach emptying

  • Liver disease

  • Kidney disease

  • Diabetes

  • Pregnant women and women who are breastfeeding

Potential Serious Adverse Health Consequences

Some of the serious risks of taking duloxetine include:

• An increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults under the age of 24 years.

• Liver damage, including liver failure.

• Orthostatic hypotension (low blood pressure with changes in position) and an associated risk of fainting and falls.

• Serotonin syndrome (a life-threatening condition due to too much serotonin in the body).

• Increased risk of bleeding.

• Severe skin reactions (hypersensitivity or allergic reactions).

• Withdrawal symptoms upon discontinuing duloxetine therapy.

• Activation of mania or hypomania in people with major depressive disorder.

• Angle-closure glaucoma.

• Seizures.

• High blood pressure.

• Drug interactions (see above).

• Low sodium levels in the blood.

• Complications in people with delayed stomach emptying.

• Risks in people with severe liver disease or severe kidney disease.

• Worsening glycemic control (blood glucose control) in people with diabetes.

• Urinary problems (hesitation and retention).

• Sexual problems in men and women.

Conclusions and Future Implications  

Current Research and Findings  

Some ongoing research on duloxetine worldwide includes:

• Anticoagulant effects of warfarin (blood thinner) when taken with duloxetine.

• Cymbalta pregnancy registry.

• Qutenza versus duloxetine for chemotherapy-induced peripheral neuropathy.

• Duloxetine hydrochloride hard gelatinous capsule versus Cymbalta.

• Duloxetine for postherpetic neuralgia.

• Duloxetine for postoperative pain in patients with tibial plateau fractures.

• Duloxetine for low back pain.

• Duloxetine versus duloxetine plus non-drug therapy for depression.

• Cymbalta for depression related to bereavement.

Monitoring Drug Safety and Patient Health  

You can find further information about medications that have been recalled due to possible nitrosamine impurities, including the latest duloxetine recall, on the FDA recalls webpage.

Steps Moving Forward for Regulatory Improvements

The U.S. Food and Drug Administration (FDA) performs regular assessments, surveillance, compliance checks, and quality control to ensure that Americans have access to safe, effective, and high-quality drugs. When any new risks are identified, such as the presence of nitrosamines in certain drugs, the FDA reacts quickly to set a proposed interim limit and then gives its final recommendations to prevent adverse health consequences.

In recent times, the availability of better testing methods has led to regulatory improvements in how and when the FDA recalls certain drugs. Advances in technology have made it possible to detect even trace amounts of impurities in pharmaceutical products. This is one of the reasons why more drugs have been recalled in recent times due to the presence of nitrosamines, including a significant amount of duloxetine bottles.