CLASS II ONGOING Drug recall · Reported 13 May 2026 · FDA Enforcement Report
Duloxetine Delayed-Release Capsules, 20 mg recalled by Ajanta Pharma
Ajanta Pharma is recalling Duloxetine Delayed-Release Capsules, 20 mg, distributed nationwide in the US. The recall was initiated on 29 Apr 2026 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-0516-2026
- FDA event ID
- 98785
- Recalling firm
- Ajanta Pharma, Aurangabad
- Brand
- Duloxetine
- Manufacturer
- Ajanta Pharma USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Apr 2026
- FDA classified
- 4 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Antidepressants
Timeline
| 29 Apr 2026 | Recall initiated by company | |
| 4 May 2026 | Classified by FDA | +5 days |
| 13 May 2026 | 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 N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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 Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Where it was distributed
Nationwide within U.S
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Which lots are affected?
Lot#: PA10734, Exp. Jun 2026.
Where was it sold?
Nationwide within U.S
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98785This product is part of a recall event; the main page for the event is Duloxetine Delayed-Release Capsules, 30 mg recalled by Ajanta Pharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Duloxetine Delayed-Release Capsules, 30 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide | |
| CLASS II | Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |
More recalls from Ajanta Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 30 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |
Other Duloxetine recalls
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine | Asclemed USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |