Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Is Isotretinoin recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Isotretinoin (20 total). Check the affected lots below.
Most common reason: Dissolution failure (10 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Isotretinoin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Isotretinoin recalls in 2026
4 initiated in 2026, 20 in total — newest first
Class II · Moderate risk
Amnesteem (Isotretinoin)
Failed Dissolution Specifications
Class II · Moderate risk
Isotretinoin Capsules
Superpotent and Subpotent
Class II · Moderate risk
Isotretinoin Capsules
Superpotent and Subpotent
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II · Moderate risk
MYORISAN (isotretinoin capsules, USP)
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Class III · Low risk
Isotretinoin Capsules
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class III · Low risk
Myorisan (isotretinoin capsules, USP)
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Class III · Low risk
Absorica (Isotretinoin)
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
Zenatane (isotretinoin)
Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk
ZENATANE (isotretinoin capsules USP)
Failed Dissolution Specifications
Class III · Low risk
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Absorica (isotretinoin)
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
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