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.
What this means for you
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.
Related recalls
Same manufacturer · Strides Pharma Inc.
See all →- HighChildren's ibuprofen suspension recalled over gel-like mass and black particles
FDA (Drugs) · 2026-03-25
- ModerateCinacalcet 90 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-08-06
- HighTestosterone Gel Recalled Nationwide Due to Benzene Contamination
FDA (Drugs) · 2025-04-02
- HighStrides Pharma Testosterone Gel Recalled Due to Benzene Contamination
FDA (Drugs) · 2025-04-02
- HighLosartan Potassium Tablets Recalled for Blue Plastic Contamination
FDA (Drugs) · 2023-07-12
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17