Teva Risedronate Tablets Recall: Failed Dissolution Specifications Risk
Teva Pharmaceuticals recalls 35mg Risedronate Sodium tablets due to failed dissolution specifications. This may affect drug effectiveness. Consumers should contact the manufacturer for details.
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Failed Dissolution Specifications
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What happened, in plain English
Teva Pharmaceuticals is recalling 35mg Risedronate Sodium Delayed-release Tablets that failed dissolution specifications. This could mean the medication doesn't work properly when taken as intended. Read more at govinfonow.com/recall/42143-teva-risedronate-tablets-recall-failed-dissolution-specifications-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42143-teva-risedronate-tablets-recall-failed-dissolution-specifications-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0431-2017
Cite this page
“Teva Risedronate Tablets Recall: Failed Dissolution Specifications Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42143-teva-risedronate-tablets-recall-failed-dissolution-specifications-risk. Based on FDA recall #D-0431-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0431-2017%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve properly as required by the manufacturer's specifications. This could mean the medication isn't absorbed by the body correctly, potentially reducing its effectiveness.
Who’s affected
People who have the specific 35mg Risedronate Sodium tablets with NDC 0093-5509-19 (4 tablets per carton) prescribed by a doctor. Those with the medication may be at risk if it doesn't dissolve correctly.
How to tell if you have this one
Look for the product name 'Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week' with NDC 0093-5509-19 on the packaging. The product is packaged in 4 blisters per carton (NDC 0093-5509-44).
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the product has NDC 0093-5509-19 and is packaged in 4 blisters per carton (NDC 0093-5509-44).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA 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 7 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-0431-2017 (December 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0431-2017 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.