Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Amlodipine Besylate Tablets Recalled by Zydus Pharmaceuticals USA Inc Due to Discoloration: Brown spots were noted embedded in Amlodipine...
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 Zydus Pharmaceuticals USA Inc directly.
Affected Products
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Quantity: 15,144 bottles
Why Was This Recalled?
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals USA Inc
Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report