FDA Drugs recall ·
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only… recall
- Recall number
- D-0101-2025
- Date
- (initiated November 14, 2024)
- Company / brand
- Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8,561 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Why was it recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025
Distribution
PA, OH, PR
States: Ohio Pennsylvania Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0101-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.