Breckenridge Pharmaceutical, Inc 2025-04-30 Health serious FDA
Health · FDA · Recall #FDA-D-0388-2025
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90),… Recall
Issued April 30, 2025 · Breckenridge Pharmaceutical, Inc
In April 2025, Breckenridge Pharmaceutical, Inc recalled the Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90),…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
What you should do
- 1 Stop using Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90),… 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
- April 30, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-D-0388-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Breckenridge Pharmaceutical, Inc has 6 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.