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Ajanta Pharma Ltd.

3 ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, 3 recalls naming Ajanta Pharma Ltd. are currently shown as ongoing.

Public Health Trace has 3 recalls naming Ajanta Pharma Ltd. as the recalling firm, republished from official FDA and USDA sources.

Recall records - 3 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20263
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FDA Recall Ongoing2026 recordClass II

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.

by Ajanta Pharma Ltd.

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.
Published
May 13, 2026
Distribution
Nationwide

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FDA Recall Ongoing2026 recordClass II

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

by Ajanta Pharma Ltd.

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.
Published
May 13, 2026
Distribution
Nationwide

View recall →

FDA Recall Ongoing2026 recordClass II

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

by Ajanta Pharma Ltd.

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.
Published
May 13, 2026
Distribution
Nationwide

View recall →

Showing 1–3 of 3 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Ajanta Pharma Ltd. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.