Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations
Is Diltiazem recalled?
Yes — there is an active recall. 9 ongoing FDA recalls mention Diltiazem (52 total). Check the affected lots below.
Most common reason: Sterility / contamination (16 of these recalls)
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 II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class II · Moderate risk
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
dilTIAZem 125mg/125mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
dilTIAZem added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
dilTIAZem added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
Diltiazem HCl in 0.7% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk
dilTIAZem HCl in 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
dilTIAZem HCl 125 mg per 125 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP)
Labelling: Incorrect Exp. Date
Class III · Low risk
Matzim LA (Diltiazem Hydrochloride)
GMP Deviation: lot not intended for commercial distribution.
Class II · Moderate risk
Diltiazem 250 mg in NS 250 mL bag
Lack of sterility assurance.
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