Potential health hazard โ use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Diltiazem Hydrochloride Extended-Release Capsules Recalled by Glenmark Pharmaceuticals Inc., USA Due to Failed Dissolution Specifications: Out of Specification (OOS) was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Glenmark Pharmaceuticals Inc., USA directly.
Affected Products
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
Quantity: 6,528 bottles
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report