Teva Risedronate Tablets Recall: Failed Dissolution Testing
Teva Pharmaceuticals recalls 35mg Risedronate Sodium Delayed-release Tablets due to failed dissolution testing. This may affect medication effectiveness. Check your product details to see if you are affected.
Lower-risk recall
Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Contact the company
What happened, in plain English
Teva Pharmaceuticals is recalling 35 mg Risedronate Sodium Delayed-release Tablets that failed dissolution testing during stability checks. This could mean the medication isn't working as intended, so affected users should check their product details and contact the manufacturer. Read more at govinfonow.com/recall/41932-teva-risedronate-tablets-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/41932-teva-risedronate-tablets-recall-failed-dissolution-testing · Updated October 8, 2026 · FDA enforcement record: FDA #D-0511-2017
Cite this page
“Teva Risedronate Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41932-teva-risedronate-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-0511-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0511-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing, meaning they may not dissolve properly in the body. This could lead to the medication not working as intended. The issue was found during stability testing, not after use.
Who’s affected
People who have the 35 mg Risedronate Sodium Delayed-release Tablets (NDC 0093-5509-19) in a 4-bottle pack. Those with osteoporosis treatment needs are most at risk.
How to tell if you have this one
Check for the product name 'Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week' in a 4-bottle pack (NDC 0093-5509-19). The manufacturer is Teva Pharmaceuticals USA.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the product name and NDC code 0093-5509-19 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the United States 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 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0511-2017 (February 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0511-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.