Claravis (isotretinoin capsule recall
FDA recall D-0521-2026 · initiated Apr 6, 2026
Teva Pharmaceuticals USA, Inc recalled Claravis (isotretinoin capsule in Apr 2026 — an FDA Class II recall (D-0521-2026) because Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,101 cartons
Details
- Product
- Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Initiated
- Apr 6, 2026
- FDA report date
- Apr 29, 2026
Frequently asked
- Was Claravis (isotretinoin capsule recalled?
- Teva Pharmaceuticals USA, Inc recalled Claravis (isotretinoin capsule in Apr 2026 — an FDA Class II recall (D-0521-2026) because Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Claravis (isotretinoin capsule recalled?
- Per the FDA enforcement record, the reason for recall D-0521-2026 was: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Is a recalled Claravis (isotretinoin capsule dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Claravis (isotretinoin capsule are affected?
- Distributed: Nationwide in the USA, Puerto Rico and Virgin Islands. The recall covers these lots — Lots#: 100067507, 100067508, Exp 07/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0521-2026.