Methoxsalen capsules recalled nationwide for failed dissolution specifications
Strides Pharma recalls Methoxsalen 10mg capsules (Lot #7253092B) due to failed dissolution specifications that could reduce medication effectiveness.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prescription medication with a manufacturing defect involving failed dissolution specifications. This represents a risk that the medication will not be properly absorbed and may fail to provide therapeutic benefit, though no illnesses or injuries have been reported.
Plain-English summary
Strides Pharma Inc. is recalling Methoxsalen Capsules, USP 10mg in 50-count bottles (396 bottles total, Lot #7253092B, expiration 09/30/2025) distributed nationwide. The recall was initiated due to failed dissolution specifications.
When a medication fails to meet dissolution specifications, it may not dissolve properly in the body, potentially reducing its ability to be absorbed and limiting therapeutic effectiveness. This is a prescription oral medication, and patients who have received affected product should contact their healthcare provider for guidance regarding their supply.
The product was manufactured by Strides Pharma Science Ltd. in Bengaluru, India (NDC 64380-752-16) and distributed by Strides Pharma Inc. in East Brunswick, New Jersey. The affected lot number is 7253092B with an expiration date of 09/30/2025.
The recalled product
- Product
- METHOXSALEN (METHOXSALEN)
- Brand
- METHOXSALEN
- Manufacturer
- Strides Pharma Inc.
- Category
- Drug — Oral Prescription
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 7253092B
- Exp Date 09/30/2025
UPCs (1)
- 0364380752165
Distribution
Distributed nationwide across the United States.
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