Alembic Pharmaceuticals Limited

6 FDA enforcement actions

6 Total Recalls

1 Class I

3 Class II

2 Class III

Firm Details

Product Types: drug
States: N/A

All Recalls

Class III: Low Risk 12/16/2025 drug

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III: Low Risk 10/10/2025 drug

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class II: Risk 07/25/2025 drug

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 05/09/2025 drug

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class II: Risk 05/07/2025 drug

Failed Impurities/Degradation Specifications
Class I: Dangerous 03/17/2021 drug

Labeling: Label-mixup

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.