Diltiazem recalls

The FDA has published 36 recalls involving Diltiazem since 2014. The latest was reported on 16 Apr 2025. Most were for potency & assay. Glenmark Pharmaceuticals Inc., USA 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 recalls36since 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 23 64%Class III 13 36%

By year

Ongoing diltiazem recalls

9 active

All diltiazem recalls, newest first

36 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., USAManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., USANitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledGlenmark Pharmaceuticals Inc., USANitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., USANitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledGlenmark Pharmaceuticals Inc., USANitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., USANitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP 90mg recalledGlenmark Pharmaceuticals Inc., USANitrosamine ImpurityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., USAPotency & AssayNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem HydrochlorideGlenmark Pharmaceuticals Inc., USAPotency & AssayNationwide
DrugCLASS IIDiltiazem HCl 125 mg in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIdilTIAZem 125mg/ (1 mg/mL), added to dextrose 5%, IV recalledCentral Admixture Pharmacy ServicesSterilityNationwide
DrugCLASS IIdilTIAZem 125mg/ (1 mg/mL), added to 0.9% sodium chloride, IV recalledCentral Admixture Pharmacy ServicesSterilityNationwide
DrugCLASS IIdilTIAZem 125mg/ (1 mg/mL), added to 0.9% sodium chloride, IV recalledCentral Admixture Pharmacy ServicesSterilityNationwide
DrugCLASS IIdilTIAZem 125mg/ (1 mg/mL), added to dextrose 5%, IV recalledCentral Admixture Pharmacy ServicesSterilityNationwide
DrugCLASS IIDiltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg recalledNephron Sterile Compounding CenterSterilityNationwide
DrugCLASS IIDiltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg recalledDiltiazem HydrochlorideSUN Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIdilTIAZem HCl in 5% Dextrose Injection, 125 mg per, (32 mcg per mL) recalledSterRxSterilityNationwide
DrugCLASS IIDiltiazem 250 mg in NS, Made by: Enterprise Pharmacy recalledCMC Enterprise PharmacySterilityNC
DrugCLASS IIIDiltiazem HCl Extended-Release Capsules, USP 180mg recalledMylan PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIICardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem CdValeant Pharmaceuticals North AmericaPotency & AssayNationwide
DrugCLASS IIICardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem CdValeant Pharmaceuticals North AmericaPotency & AssayNationwide
DrugCLASS IIICardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem CdValeant Pharmaceuticals North AmericaPotency & AssayNationwide
DrugCLASS IIICardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem CdValeant Pharmaceuticals North AmericaPotency & AssayNationwide
DrugCLASS IIIDiltiazem HCl Extended-Release Capsules, USP 120 mg recalledMylan PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIDiltiazem HCl Extended-Release Capsules, USP 120 mg recalledMylan PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIDiltiazem HCl Extended-release Capsules, USP 120 mg recalledMylan Institutional, Inc. (d.b.a. UDL Laboratories)Potency & AssayNationwide
DrugCLASS IIDiltiazem HCL 1 mg/mL in 0.9% Sodium Chloride bag recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIIDiltiazem HCl Extended-Release Capsules, USP 120 mg recalledMckesson Packaging ServicesPotency & AssayNationwide
DrugCLASS IIIDiltiazem HCl Extended-Release Capsules, USP 240 mg recalledMckesson Packaging ServicesPotency & AssayNationwide
DrugCLASS IIDiltiazem HCl 125 mg in 5% Dextrose Single-Dose recalledCantrell DrugSterilityNationwide

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.