November 21, 2019
Amneal Pharmaceuticals Inc. is recalling several batches of isotretinoin capsules, 10 mg, because tretinoin levels in the drug are slightly above specification limits, according to the November 20, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall spans 2460 cartons of isotretinoin, each containing three blister packs of 10 capsules for a total of 30 capsules per carton (NDC 69238-1174-3), from three batches: BL10917, BL11017, and BL11117 (Exp. 11/19). The affected isotretinoin was distributed to retailers and wholesalers that may have further distributed the product.
Amneal Pharmaceuticals voluntarily initiated the recall October 16, 2019. On November 13, 2019, the FDA designated the recall Class III. Under the recall classification, use of the affected capsules is not likely to cause harm.
Isotretinoin is a prescription medication used to treat severe acne.