Glenmark Diltiazem Extended-Release Capsules recalled for manufacturing deviations
Glenmark Pharmaceuticals is voluntarily recalling Diltiazem Hydrochloride 120mg Extended-Release Capsules nationwide due to manufacturing process deviations. Consumers should verify lot numbers and consult their pharmacist.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing deviations (CGMP violations) on a prescription medication. While no illnesses have been reported, CGMP violations represent a significant quality control issue that could affect drug safety and efficacy.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 120mg in 100-count bottles (NDC 68462-562-01). The affected lots are 17241067 (expires May 2026) and 17241628 (expires August 2026). The product has been distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The capsules were manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India.
Diltiazem Hydrochloride is a prescription medication. Patients currently using this product with one of the recalled lot numbers may be affected.
Consumers should check the lot number on their medication bottle. Patients with a recalled lot should contact their pharmacy or healthcare provider for guidance on their medication status and to discuss alternative treatment options.
The recalled product
- Product
- DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 17241067
- exp. date May-26 17241628
- exp. date Aug-26
UPCs (3)
- 0368462562017
- 0368462851012
- 0368462850015
Distribution
Distributed nationwide across the United States.
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