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Alembic Pharmaceuticals Limited

5 ongoing recalls and 2 historical records

Based on the official records currently available to Public Health Trace, 5 recalls naming Alembic Pharmaceuticals Limited are currently shown as ongoing. The other 2 records below are historical.

Public Health Trace has 7 recalls naming Alembic Pharmaceuticals Limited as the recalling firm, republished from official FDA and USDA sources.

Recall records - 7 total

Recalls by year

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

Recalls by year
YearRecalls
20201
20211
20254
20261
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FDA Recall Ongoing2026 recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

by Alembic Pharmaceuticals Limited

Reason
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Published
January 14, 2026
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

by Alembic Pharmaceuticals Limited

Reason
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Published
November 26, 2025
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

by Alembic Pharmaceuticals Limited

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Published
August 13, 2025
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

by Alembic Pharmaceuticals Limited

Reason
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Published
June 18, 2025
Distribution
Nationwide

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FDA Recall OngoingHistorical recordClass II

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

by Alembic Pharmaceuticals Limited

Reason
Failed Impurities/Degradation Specifications
Published
June 4, 2025
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 5, 2022Historical recordClass I

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

by Alembic Pharmaceuticals Limited

Reason
Labeling: Label-mixup
Published
April 14, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: January 19, 2022Historical recordClass II

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.

by Alembic Pharmaceuticals Limited

Reason
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Published
July 1, 2020
Distribution
Nationwide

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Showing 1–7 of 7 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 Alembic Pharmaceuticals Limited 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.