Diltiazem Hydrochloride Extended-Release Capsules recall
FDA recall D-0430-2024 · initiated Mar 26, 2024
Glenmark Pharmaceuticals Inc., USA recalled Diltiazem Hydrochloride Extended-Release Capsules in Mar 2024 — an FDA Class II recall (D-0430-2024) because Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 6,528 bottles
Details
- Product
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Mar 26, 2024
- FDA report date
- Apr 10, 2024
Frequently asked
- Was Diltiazem Hydrochloride Extended-Release Capsules recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Diltiazem Hydrochloride Extended-Release Capsules in Mar 2024 — an FDA Class II recall (D-0430-2024) because Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. 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-0430-2024 was: Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- 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 US. The recall covers these lots — Lot #: 17230304, Exp. 12/31/2024.. 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-0430-2024.