Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tamsulosin Hydrochloride Capsules Recalled by Macleods Pharma Usa Inc Due to Failed Dissolution Specifications

Date: July 17, 2019
Company: Macleods Pharma Usa 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 Macleods Pharma Usa Inc directly.

Affected Products

Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA

Quantity: a) 5448 bottles b) 972 bottles c) 158 bottles

Why Was This Recalled?

Failed Dissolution Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Macleods Pharma Usa Inc

Macleods Pharma Usa Inc has 28 total recalls tracked by RecallDetector.

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