Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alendronate Sodium Tablets Recalled by Sun Pharma Global Fze Due to Failed Impurities/Degradation Specifications: Observed levels of highest unknown...
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 Sun Pharma Global Fze directly.
Affected Products
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Quantity: 381,120 cartons
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharma Global Fze
Sun Pharma Global Fze has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report