Duloxetine D/R 20 mg Recall: Nitrosamine Impurity
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Duloxetine D/R 20 mg recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
Which lot codes, UPCs or models are affected?
Lot #: 02AU2406, Exp 01/31/2027
- Agency record number
- D-0567-2025
- Product
- Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
- Recalling firm
- Direct Rx
- Quantity
- 16 bottles
- Distribution
- Nationwide
- Recall started
- March 7, 2025
- Report date
- August 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)