Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Is Diltiazem recalled?
Yes — there is an active recall. 9 ongoing FDA recalls mention Diltiazem (52 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Diltiazem. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Diltiazem recalls on record
none so far in 2026; 52 on record, newest first
Class III · Low risk
Diltiazem HCl CD capsules
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Cardizem CD
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class II · Moderate risk
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem CD
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Class II · Moderate risk
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag
Lack of Sterility Assurance.
Class II · Moderate risk
Diltiazem 125 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
Diltiazem HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: OOS results for known compound.
Class II · Moderate risk
Diltiazem HCI 250 mg in 5% Dextrose
Lack of Assurance of Sterility
Class II · Moderate risk
All diltiazem Products
Lack of Processing Controls
Class III · Low risk
Cartia XT (diltiazem HCl extended-release capsules, USP)
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk
Diltiazem HCl Extended Release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class II · Moderate risk
Diltiazem HCL
Labeling: Label Mixup: DILTIAZEM HCL, Tablet, 120 mg, may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: AD329737, EXP: 5/9/2014.
Class II · Moderate risk
DILTIAZEM HCL ER Capsule
Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014; PARoxetine HCl, Tablet, 10 mg, NDC 13107015430, Pedigree: AD52778_67, EXP: 5/20/2014.
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