FDA-Drug2026-06-17Class IICHEMICAL
Breckenridge Duloxetine 30mg capsules recalled for N-nitroso impurity above FDA limit
What this means
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.
The agency's original wording
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Intended for
Adults
Illnesses reported
None reported
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-0582-2026Want us to check the next one for you?
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