Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NIFEdipine EXTENDED-RELEASE TABLETS Recalled by The Harvard Drug Group Due to Failed Dissolution Specification: Out of specification for dissolution...
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 The Harvard Drug Group directly.
Affected Products
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
Quantity: 504 Cartons of 50 count each; 372 Cartons of 100 count each
Why Was This Recalled?
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Where Was This Sold?
This product was distributed to 2 states: NJ, OH
About The Harvard Drug Group
The Harvard Drug Group has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report