20 FDA recalls mention Isotretinoin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Isotretinoin.
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Reason Failed Dissolution Specifications
Reason Superpotent and Subpotent
Reason Superpotent and Subpotent
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Reason Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of…
Reason Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Reason Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Reason Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Reason Failed Dissolution Specifications
Reason Failed Impurities/Degradation Specifications.
Reason Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
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