Direct Rx 2025-08-13 Health serious FDA
Health · FDA · Recall #FDA-D-0567-2025
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by:… Recall
Issued August 13, 2025 · Direct Rx
In August 2025, Direct Rx recalled the Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by:…, 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 Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
What you should do
- 1 Stop using Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Direct Rx 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
- Direct Rx
- Category
- Health
- Recall date
- August 13, 2025
- Units affected
- Not reported
- Sold at
- Nationwide
- Recall number
- FDA-D-0567-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Direct Rx has 17 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.