Class II — Potential Health Hazard

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

Glycopyrrolate Tablets Recalled by Par Pharmaceutical Inc. Due to Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Date: March 30, 2020
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

Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg. by: Par Formulations Private Limited, 1/58, Pudupakkam, Kelambakkam - 603 103., Made in India NDC# 49884-0065-01

Quantity: 29,352 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specification: Presence of unknown impurity observed.

Where Was This Sold?

Product was distributed within the United States.

About Par Pharmaceutical Inc.

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

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