Drug & Device Safety Atlas

FDA recall record · openFDA

STRIDES PHARMA INC

6 FDA recalls on record (2023–2026) — 6 drug. 4 still ongoing.

0
Class I (most serious)
6
Class II
0
Class III
4
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Presence of foreign substance: Presence of Benzene. 2
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. 1
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. 1
Failed Dissolution Specifications 1
Failed Dissolution Specifications. 1

Recalls

Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceutica Class II 2026-03-02 Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Bruns Class II 2025-03-05 Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Dis Class II 2025-07-09 Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Br Class II 2025-03-05 Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Scie Class II 2023-06-26 Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 56210 Class II 2023-12-29

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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