Sun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Issues
Sun Pharma Global Fze recalls Alendronate Sodium Tablets, USP, 70 mg due to failed impurity specifications. Check your lot numbers for details.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
Contact the company
What happened, in plain English
Sun Pharma Global Fze is recalling Alendronate Sodium Tablets, USP, 70 mg because the highest unknown impurity levels exceeded specification limits at the three-month stability time point. The recall affects 381,120 cartons distributed nationwide and in Puerto Rico. The record does not specify any reported injuries or a current remedy for consumers. Read more at govinfonow.com/recall/43161-sun-pharma-recalls-alendronate-sodium-tablets-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/43161-sun-pharma-recalls-alendronate-sodium-tablets-due-to-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0735-2016
Cite this page
“Sun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43161-sun-pharma-recalls-alendronate-sodium-tablets-due-to-impurity-issues. Based on FDA recall #D-0735-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0735-2016%22&limit=1).
Why it’s dangerous
The recalled tablets failed to meet impurity specifications, with observed levels of the highest unknown impurity exceeding limits at the three-month stability time point. While the record does not describe specific health effects from this impurity, deviations in pharmaceutical standards can potentially impact the safety or efficacy of the medication.
Who’s affected
Patients who have been prescribed Alendronate Sodium Tablets, USP, 70 mg by their healthcare provider are affected. Individuals in the United States and Puerto Rico who purchased these specific cartons are at risk of receiving a product that does not meet purity specifications.
How to tell if you have this one
Look for Alendronate Sodium Tablets, USP, 70 mg in 4-count blisters per carton. The product is Rx only and distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ. Check your carton for NDC 41616-638-68, UPC 3 41616 63868 4, and Lot numbers JKP2234A or JKP2235A with an expiration date of 04/17.
- Brand
Sun Pharma- Product
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Alendronate Sodium Tablets match the recalled NDC, UPC, and lot numbers (JKP2234A or JKP2235A) with an expiration date of 04/17.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for your prescription, as no specific consumer remedy is listed in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0735-2016 (February 11, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0735-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.