CLASS II ONGOING Drug recall · Reported 13 Aug 2025 · FDA Enforcement Report
Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx
Direct Rx is recalling Duloxetine D/R, 20 mg, 30 Caps, distributed nationwide in the US. The recall was initiated on 7 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0567-2025
- FDA event ID
- 97251
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Mar 2025
- FDA classified
- 4 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Antidepressants
Timeline
| 7 Mar 2025 | Recall initiated by company | |
| 4 Aug 2025 | Classified by FDA | +150 days |
| 13 Aug 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Duloxetine D/R, 20 mg, 30 Caps recalled?
Yes. Direct Rx recalled Duloxetine D/R, 20 mg, 30 Caps on 7 Mar 2025. The recall is Class II and its status is Ongoing. Recall number D-0567-2025.
Why was it recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Which lots are affected?
Lot #: 02AU2406, Exp 01/31/2027
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Direct Rx
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
| Drug | CLASS II | Alprazolam C-IV, 5 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |