Teva recalls Claravis 10mg capsules due to impurities and degradation
Teva North America recalls Claravis 10mg capsules (NDC 00555-1:1054-86) for failed impurities and degradation specifications. This prescription-only medication was sold with a specific lot number and expiration date.
Recall notice
Failed Impurities/Degradation Specifications.
Contact the company
What happened, in plain English
Teva North America has recalled Claravis 10mg capsules that may contain impurities or have degraded. This recall affects prescription-only medication sold with a specific lot number and expiration date. Read more at govinfonow.com/recall/42495-teva-recalls-claravis-10mg-capsules-due-to-impurities-and-degradation.
Source Summary by GovInfoNow · govinfonow.com/recall/42495-teva-recalls-claravis-10mg-capsules-due-to-impurities-and-degradation · Updated October 9, 2026 · FDA enforcement record: FDA #D-0005-2017
Cite this page
“Teva recalls Claravis 10mg capsules due to impurities and degradation.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42495-teva-recalls-claravis-10mg-capsules-due-to-impurities-and-degradation. Based on FDA recall #D-0005-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0005-2017%22&limit=1).
Why it’s dangerous
The capsules may contain impurities or have degraded, which could lead to health risks. However, the specific health risks are not detailed in the recall notice.
Who’s affected
Prescription patients who received Claravis 10mg capsules with NDC 00555-1054-86 and lot number 34025714A before December 2016 are affected. Those using the medication without a prescription are not impacted.
How to tell if you have this one
Check for the product name 'Claravis', 10mg capsules, and the lot number 34025714A with an expiration date of December 2016. The product is sold by Teva North America in cartons with 3 blister packs of 10 capsules each.
- Brand
Teva- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the product packaging to confirm if it matches the recalled batch.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” 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-0005-2017 (August 5, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0005-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.