Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is DILTIAZEM HYDROCHLORIDE recalled?

The FDA has recorded 10 recalls of DILTIAZEM HYDROCHLORIDE (2023–2025) , recalled under brand like DILTIAZEM HYDROCHLORIDE. 9 still ongoing.

0
Class I (most serious)
10
Class II
0
Class III
9
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of DILTIAZEM HYDROCHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. 6
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time 1
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing 1
CGMP Deviations 1
Failed Dissolution Specifications 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Phar Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2025-03-13 lots: Lot # 17241067, exp. date May-26 17241628, exp. date Aug-26
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd f Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-11-01 lots: Lot #: 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmac Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-11-01 lots: Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-11-01 lots: Lot #:17222547, Exp. Date, 11/30/2024; 17230598, Exp. Date 02/28/2025
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-03-26 lots: Lot #: 17230304, Exp. 12/31/2024.
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manu Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-11-01 lots: Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-11-01 lots: Lot #: 17222544, Exp 11/30/2024.
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmac Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-11-01 lots: Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Man Class II ongoing
Glenmark Pharmaceuticals Inc., USA 2024-04-17 lots: Lot #: 17221312, Exp. 5/31/2024
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmace Class II Terminated
SUN PHARMACEUTICAL INDUSTRIES INC 2023-01-13 lots: Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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