Class III โ€” Low Risk

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

Pramipexole Dihydrochloride Tablets 0.125 mg Recalled by Macleods Pharma Usa Inc Due to Subpotent Drug: Out of specification result during stability...

Date: August 21, 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

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10

Quantity: 1837 90-count bottles

Why Was This Recalled?

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

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.

Related Recalls

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