Class III โ€” Low Risk

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

Clonazepam Tablets Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Due to Failed Impurities/Degradation Specifications: out of specification result for...

Date: September 28, 2016
Company: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
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 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) directly.

Affected Products

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505

Quantity: 1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)

Why Was This Recalled?

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 22 total recalls tracked by RecallDetector.

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