Duloxetine recall: What patients should check before changing medication

by Brandon Burley and The Redemption Project A recall involving certain bottles of generic duloxetine delayed-release capsules has raised questions for patients who take the medication for depression, anxiety, nerve pain and other conditions. The most important guidance is practical: check the bottle, call the pharmacy and do not stop the medication abruptly without medical guidance. The recall does not affect every duloxetine prescription. It involves specific lots of duloxetine delayed-release capsules, USP, in 30 mg and 60 mg strengths. Duloxetine is the generic form of the medication commonly known by the brand name Cymbalta. The affected medication was manufactured by Towa Pharmaceutical Europe, S.L., and distributed in the United States by Breckenridge Pharmaceutical, Inc., according to FDA-related recall records and current public reporting. The recall was issued because some products may contain N-nitroso-duloxetine, a nitrosamine impurity, above the Food and Drug Administration’s recommended limit. Nitrosamines are impurities that can be found in some medications. The FDA says nitrosamines are also found in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. The concern is not that one capsule is expected to cause immediate harm. The concern is that nitrosamine impurities may increase cancer risk if people are exposed above acceptable levels over long periods of time. The FDA classified the recall as Class II. Under FDA definitions, a Class II recall means use of or exposure to a product may cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote. That classification does not mean patients should ignore the recall. It also does not mean patients should panic. Patients should first determine whether their medication is actually part of the recall. That means checking the drug name, manufacturer or distributor, strength, lot number and expiration date on the bottle or pharmacy paperwork. If that information is hard to find, patients should call the pharmacy that filled the prescription. The affected products include duloxetine delayed-release capsules in 30 mg and 60 mg strengths. Public recall reporting has identified affected 30 mg products in 1,000-count bottles and affected 60 mg products in 90-count and 1,000-count bottles. Patients should verify the specific lot number and expiration date with their pharmacy rather than relying only on the medication name. That matters because drug recalls are usually specific. They often apply to certain manufacturers, strengths, bottle sizes, lot numbers and expiration dates, not every version of a medication. Share Public recall information describes the affected product as distributed nationwide through retail-level pharmacy channels. It does not identify every pharmacy chain or location that may have dispensed the affected lots. That means patients should not assume they are unaffected based only on where the prescription was filled. A patient who received duloxetine through a chain pharmacy, independent pharmacy, mail-order pharmacy, VA pharmacy or other pharmacy should verify the specific manufacturer and lot number. The practical question is not whether a pharmacy carried duloxetine in general. It is whether a patient’s specific bottle came from an affected Breckenridge/Towa lot. Patients who believe they have recalled medication should contact their pharmacist or prescribing clinician. A pharmacist may be able to replace the medication with duloxetine from a nonrecalled lot or help coordinate next steps with the prescriber. That step is especially important with duloxetine. Stopping duloxetine suddenly may cause withdrawal symptoms or a return or worsening of the condition being treated. Any change should be made with medical guidance. Patients can ask their pharmacy four direct questions: Is my duloxetine from Breckenridge Pharmaceutical or Towa Pharmaceutical Europe? What is the NDC, lot number and expiration date on the medication I received? Is my bottle part of the current recall? Can you replace it with duloxetine from a nonrecalled lot or contact my prescriber about an alternative? Patients should keep the bottle and any paperwork until the pharmacy or prescriber gives further instructions. They should not throw away medication before confirming whether it is affected and what replacement plan is available. The recall is a reminder that prescription drug recalls usually require verification, not guesswork. For patients taking duloxetine, the next step is not fear. It is confirmation. Check the bottle. Call the pharmacy. Follow medical guidance before making any medication change. Sources: Food and Drug Administration recall guidance and nitrosamine information; FDA-related recall records; ABC News; Health.com. I am a retired detective and criminal justice / government educator based in Tennessee. I am a commentary write for Tennessee Lookout and a weekly columnist with Knox TN Today . My work examines public policy, public safety systems and civic responsibility. My reporting and commentary have also appeared in Governing , The Arizona Capitol Times , South Florida Sun Sentinel , Police1 , among other state and regional outlets. Subscribe now