CW ClaimWatch Consumer alert tracker

Recall

Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, 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. Product details: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

Active Official source

Verification

Official-source record

This page is included in the public index because it is tied to a listed official source. ClaimWatch does not publish trend-only candidates to public SEO pages.

Agency
FDA
Record ID
D-0515-2026
Canonical
https://claimwatch-mvp.vercel.app/item/ajanta-pharma-ltd-duloxetine-delayed-release-capsules-60-mg-rx-only-30-capsules-marketed-b/

What happened?

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. Product details: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

Who may be affected?

Nationwide within U.S

What should consumers do?

Affected quantity: 77,376 packs.

Official source

Matched search terms

No search trend terms attached yet.

FAQ

Is this page official?

No. ClaimWatch links to official sources and marks whether a page is verified or still being monitored.

Is this legal, medical, or financial advice?

No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

Similar alerts