Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Pramipexole Dihydrochloride Tablets Recalled by Sandoz Incorporated Due to Impurities/Degradation Products: An out of specification result for...
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 Sandoz Incorporated directly.
Affected Products
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Quantity: 41,761bottles.
Why Was This Recalled?
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz Incorporated
Sandoz Incorporated has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report