Glenmark recalls Diltiazem Hydrochloride ER Capsules for Dissolution failure

Glenmark has initiated a recall of one lot of Diltiazem Hydrochloride 120mg, Extended Release(ER) Capsules in US in Mar 2024. The class II recall is due to Failed Dissolution Specifications during long term stability studies at the at the 12th month time point. Diltiazem HCl is indicated for treatment of hypertension.

The dissolution test related recall incidents of Diltiazem Hydrochloride ER Capsules are not isolated. An analysis of USFDA Enforcement data show that there have been multiple recalls associated with Diltiazem HCl Extended Release Capsules for dissolution related issues. There were 12 recalls reported for Diltiazem HCl for dissolution related issues from year 2018 till date by different manufacturers.

Year                     Number of recalls                       Recalling Firm

2018                                   3                                     Par Pharmaceuticals, Actavis

2019                                   5                                     Valeant

2022                                   2                                     Teva/Actavis

2023                                   1                                     Sun Pharmaceuticals

2024                                   1                                     Glenmark

These recalls underscore the importance of rigorous manufacturing process controls,  quality control and ongoing monitoring throughout a drug’s lifecycle for Diltiazem Hydrochloride ER Capsules

USFDA Enforcement Report