⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India,

DrugsSource: FDA (drug) · Date: 2026-05-13

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Get alerts for Ajanta Pharma

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Ajanta Pharma Ltd.
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.
Reason / hazard
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
Status
Ongoing
Distribution / sold at
Nationwide within U.S
Recall initiated
2026-04-29
Code info
Lot#: PA10734, Exp. Jun 2026.
Product quantity
117,168 packs
Voluntary mandated
Voluntary: Firm initiated
City
Aurangabad
Country
India
Event id
98785
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.