Duloxetine Delayed-Release Capsules recall
FDA recall D-0516-2026 · initiated Apr 29, 2026
Ajanta Pharma Ltd. recalled Duloxetine Delayed-Release Capsules in Apr 2026 — an FDA Class II recall (D-0516-2026) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 117,168 packs
Details
- Product
- 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.
- Recalling company
- Ajanta Pharma Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within U.S
- Initiated
- Apr 29, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was Duloxetine Delayed-Release Capsules recalled?
- Ajanta Pharma Ltd. recalled Duloxetine Delayed-Release Capsules in Apr 2026 — an FDA Class II recall (D-0516-2026) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine Delayed-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0516-2026 was: 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.
- Is a recalled Duloxetine Delayed-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Duloxetine Delayed-Release Capsules are affected?
- Distributed: Nationwide within U.S. The recall covers these lots — Lot#: PA10734, Exp. Jun 2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0516-2026.