Diltiazem recalls

The FDA has published 26 recalls involving Diltiazem since 2014. The latest was reported on 16 Apr 2025. Most were for potency & assay. Glenmark Pharmaceuticals Inc., U has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls26since 2014
Last 12 months0reported
Class I00% of total
Ongoing9latest 16 Apr 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 12 46%Class III 14 54%

By year

Ongoing diltiazem recalls

9 active

All diltiazem recalls, newest first

26 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., UManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., UNitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledGlenmark Pharmaceuticals Inc., UNitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., UNitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledGlenmark Pharmaceuticals Inc., UNitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., UNitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP 90mg recalledGlenmark Pharmaceuticals Inc., UNitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg recalledDiltiazem HydrochlorideSun Pharmaceutical IndustriesPotency & AssayNationwide

Should you stop taking Diltiazem?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.