Breckenridge Pharmaceutical, Inc. 2025-07-16 Health serious FDA
Health · FDA · Recall #FDA-D-0511-2025
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by:… Recall
Issued July 16, 2025 · Breckenridge Pharmaceutical, Inc.
In July 2025, Breckenridge Pharmaceutical, Inc. recalled the Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
What you should do
- 1 Stop using Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Breckenridge Pharmaceutical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Breckenridge Pharmaceutical, Inc.
- Category
- Health
- Recall date
- July 16, 2025
- Units affected
- Not reported
- Sold at
- U.S. Nationwide
- Recall number
- FDA-D-0511-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Breckenridge Pharmaceutical, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.