Photochemotherapy Capsules Recalled

Strides Pharma Inc. is recalling 396 bottles of methoxsalen capsules because samples failed to meet dissolution specifications during routine testing, according to the January 31, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects methoxsalen capsules, 10 mg, in 50-count bottles (NDC 64380-752-16) from lot 7253092B (Exp. 9/30/25). The capsules were manufactured by Strides Pharma Science Ltd., Bengaluru, India, and were distributed by Strides Pharma Inc., East Brunswick, New Jersey, throughout the United States.

Strides Pharma voluntarily initiated the recall December 29, 2023. On January 24, 2024, the FDA designated it Class II, signaling use of the drug could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Methoxsalen is a prescription medication intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation. The photochemotherapy is indicated for symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy.