Potential health hazard — 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 cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA...
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 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-555-01.
Quantity: 7296 bottles
Why Was This Recalled?
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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