Duloxetine Delayed-Release Capsules, USP, 30mg, 1000… was recalled on June 4, 2026 in cooperation with the U.S. Food and Drug Administration because CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Lot: 241180C, Exp. Date April 2027.
Units affected: 14,729 bottles.
Where it was sold: Nationwide within the United States
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Breckenridge Pharmaceutical, Inc.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Dissolution Specifications
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