Teva Recalls Claravis 10mg Due to Impurity Issues
Teva Pharmaceuticals recalls specific lots of Claravis 10mg capsules due to failed impurity specifications. Check your lot numbers and expiration date.
Recall notice
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA, Inc. is recalling specific lots of Claravis (isotretinoin capsule, USP), 10 mg, because they failed impurity specifications for the specific impurity Tretinoin. The recall affects 5,101 cartons distributed nationwide in the USA, Puerto Rico, and Virgin Islands. The record does not specify a remedy or what consumers should do with the product. Read more at govinfonow.com/recall/31362-teva-recalls-claravis-10mg-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/31362-teva-recalls-claravis-10mg-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-0521-2026
Cite this page
“Teva Recalls Claravis 10mg Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31362-teva-recalls-claravis-10mg-due-to-impurity-issues. Based on FDA recall #D-0521-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0521-2026%22&limit=1).
Why it’s dangerous
The recalled product failed specifications for a specific impurity called Tretinoin. The record does not describe the health risks or mechanism of injury associated with this impurity level.
Who’s affected
Patients prescribed Claravis 10 mg capsules who purchased the affected lots between distribution and the recall date. Individuals in the USA, Puerto Rico, and Virgin Islands are potentially affected.
How to tell if you have this one
Check your Claravis packaging for NDC 0555-1054-56 (100-count carton), NDC 0555-1054-86 (30-count carton), or blister packs with NDC 0555-1054-60. Verify the lot numbers are 100067507 or 100067508 and the expiration date is 07/31/2026.
- Brand
Teva- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA, Puerto Rico and Virgin Islands” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
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-0521-2026 (April 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0521-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b 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.