Sun Pharmaceutical Industries, Inc. is recalling 47,520 prescription packs of Absorica (isotretinoin) Capsules 30 mg. Routine testing revealed that the medication was subpotent, meaning the level of the active ingredient, isotretinoin, was lower than the required quality standards. This defect could make the medication less effective at treating the patient's condition as intended. The affected capsules were distributed nationwide in 30-count prescription packs containing three 10-capsule blister packs.
Because the medication contains less active ingredient than specified, patients may not receive the full therapeutic dose required for their treatment. This could lead to a reduced clinical response or ineffective treatment of severe acne.
Healthcare provider guidance and pharmacy refund.
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Sources: FDA iRES · Raw API Response
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