Quick Facts at a Glance
- Recall Date
- April 29, 2026
- Hazard Level
- HIGH
- Brands
- DULOXETINE, Ajanta Pharma USA Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DULOXETINE, Ajanta Pharma USA Inc.
- Model numbers
- Lot#: PA10734, Exp. Jun 2026.
- UPC codes
- 27241-097, 27241-098, 27241-164, 27241-099, 27241-097-06, 27241-097-10, 27241-097-90, 27241-097-05 +6 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 29, 2026
Reported by FDA DRUG
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Ajanta Pharma Ltd. or your healthcare provider for guidance. Notification method: Letter
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Full Description
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.. Generic: DULOXETINE; Brand: DULOXETINE. Reason: 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.. Classification: Class II. Quantity: 117,168 packs. Distribution: Nationwide within U.S
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Safety Guide
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