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 extended release tablets Recalled by Par Pharmaceutical, Inc. Due to Failed impurities/degradation specifications: Finished product contain a known...

Date: September 6, 2018
Company: Par Pharmaceutical, 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 Par Pharmaceutical, Inc. directly.

Affected Products

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Quantity: 16,207 (bottles of 30 tablets)

Why Was This Recalled?

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Par Pharmaceutical, Inc.

Par Pharmaceutical, Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

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