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Ajanta Pharma USA Inc

4 ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, 4 recalls naming Ajanta Pharma USA Inc are currently shown as ongoing.

Public Health Trace has 4 recalls naming Ajanta Pharma USA Inc as the recalling firm, republished from official FDA and USDA sources.

Recall records - 4 total

Recalls by year

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

Recalls by year
YearRecalls
20264
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FDA Recall Ongoing2026 recordClass II

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

by Ajanta Pharma USA Inc

Reason
Failed Dissolution Specifications: below specification
Published
October 7, 2026
Distribution
Nationwide

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FDA Recall Ongoing2026 recordClass III

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.

by Ajanta Pharma USA Inc

Reason
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Published
September 16, 2026
Distribution
Nationwide

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FDA Recall Ongoing2026 recordClass II

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.

by Ajanta Pharma USA Inc

Reason
CGMP Deviations
Published
July 1, 2026
Distribution
Nationwide

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FDA Recall Ongoing2026 recordClass II

Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.

by Ajanta Pharma USA Inc

Reason
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Published
June 24, 2026
Distribution
Nationwide

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Showing 1–4 of 4 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 USA Inc 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.

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