Food, drugs, devices › Strides Pharma Inc.
Drug recall: Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 56210
FDA enforcement event 93703 is a drug recall by Strides Pharma Inc. of East Brunswick, NJ, initiated 29 Dec 2023 and classified Class II, with 1 product record.
FDA defines Class II as 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. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 1 Jul 2025. Initiation: voluntary: firm initiated. Strides Pharma Inc. has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Strides Pharma Inc., East Brunswick, NJ.
Reason for recall
"Failed Dissolution Specifications"
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0260-2024 | 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 | 396 50-count bottles | Class II | Terminated | 31 Jan 2024 |
Context
Other enforcement events for Strides Pharma Inc.
All 10 events for Strides Pharma Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Specifications"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.