Amerisource Health Services LLC 2025-01-01 Health serious FDA
Health · FDA · Recall #FDA-D-0155-2025
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured… Recall
Issued January 1, 2025 · Amerisource Health Services LLC
In January 2025, Amerisource Health Services LLC recalled the Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
What you should do
- 1 Stop using Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amerisource Health Services LLC 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
- Amerisource Health Services LLC
- Category
- Health
- Recall date
- January 1, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0155-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Amerisource Health Services LLC has 20 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.