Diltiazem Hydrochloride Extended-Release Capsules recall
FDA recall D-0094-2025 · initiated Nov 1, 2024
Glenmark Pharmaceuticals Inc., USA recalled Diltiazem Hydrochloride Extended-Release Capsules in Nov 2024 — an FDA Class II recall (D-0094-2025) because cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12,864 bottles
Details
- Product
- Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Nov 1, 2024
- FDA report date
- Dec 11, 2024
Frequently asked
- Was Diltiazem Hydrochloride Extended-Release Capsules recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Diltiazem Hydrochloride Extended-Release Capsules in Nov 2024 — an FDA Class II recall (D-0094-2025) because cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Diltiazem Hydrochloride Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0094-2025 was: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
- Is a recalled Diltiazem Hydrochloride Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Diltiazem Hydrochloride Extended-Release Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0094-2025.