Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Benzonatate capsules Recalled by Strides Pharma INC Due to Failed Stability Specifications: Out of Specification results obtained...

Date: May 9, 2017
Company: Strides Pharma INC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Strides Pharma INC directly.

Affected Products

Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06

Quantity: 127,517 bottles

Why Was This Recalled?

Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Strides Pharma INC

Strides Pharma INC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report