CLASS II Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Methoxsalen Capsules, USP 10mg recalled by Strides Pharma
Strides Pharma is recalling Methoxsalen Capsules, USP 10mg, distributed nationwide in the US. The recall was initiated on 29 Dec 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0260-2024
- FDA event ID
- 93703
- Recalling firm
- Strides Pharma, East Brunswick, NJ
- Brand
- Methoxsalen
- Manufacturer
- Strides Pharma Science Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Dec 2023
- FDA classified
- 24 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 Dec 2023 | Recall initiated by company | |
| 24 Jan 2024 | Classified by FDA | +26 days |
| 31 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: 7253092B, Exp Date 09/30/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Strides Pharma
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets 90 mg recalled by Strides PharmaCinacalcet | Strides Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Gel 1%-dose packets recalled by Strides PharmaTestosterone | Strides Pharma | Benzene | Nationwide |
| Drug | CLASS II | Testosterone Gel 1%-dose Packets recalled by Strides PharmaTestosterone | Strides Pharma | Benzene | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium | Strides Pharma | Foreign Material | Nationwide |