FDA Recalls Bottles of Duloxetine Due to Cancer Risk
In 2024, the U.S. Food and Drug Administration (FDA) announced a voluntary, manufacturer-initiated recall of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.
The recall was initiated on October 10 by Breckenridge Pharmaceutical and covers 7,107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI. The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.
On November 19, the recall was expanded by distributor Rising Pharmaceuticals Inc. to include an additional 233,003 bottles of delayed-release capsules in 20 mg, 30 mg, and 60 mg doses. Refer to the full list of products included in the FDA’s latest duloxetine recall.
What is Duloxetine?
Duloxetine (the generic name for Cymbalta) is a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat depression, anxiety, and some forms of long-term pain from fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy. Chronic pain and neuropathic pain may be caused by trauma and are sometimes seen in workers’ compensation claims.
Reason for FDA Recall
The medication recall is due to the detection of elevated levels of the nitrosamine impurity, N-nitroso duloxetine. Nitrosamines are common in water and foods but exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.
MyMatrixx Response
MyMatrixx transaction records indicate that scripts for Duloxetine are low for our book of business. If you have any questions about this recall, please contact your MyMatrixx account team.