FDA-Drug2026-06-17Class IICHEMICAL
Breckenridge Duloxetine 30mg capsules recalled for N-nitroso impurity above FDA limit
HEAVY METALSNationwide distribution
Breckenridge Duloxetine capsules recalled for impurity concern
Breckenridge Pharmaceutical is recalling one lot of Duloxetine Delayed-Release Capsules 30mg due to the presence of N-nitroso-duloxetine impurity above FDA's recommended interim limit. This is a manufacturing quality issue. No injuries have been reported.
- Check if you have lot 241180C with expiration date April 2027.
- Contact your pharmacist or doctor before stopping this medication.
- Your pharmacist can help you obtain a replacement prescription.
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Sold states
Nationwide within the United States
Affected count
14,729 bottles.
Manufactured in
200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2026More Breckenridge Pharmaceutical, Inc. recalls
- FDA-Drug2026-06-17Breckenridge Duloxetine 60mg capsules recalled for high impurity levels
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