Medications & Supplements/Prescription Drugs

Par Pharmaceutical Inc.: Glycopyrrolate Tablets Recalled for Presence of Unknown Impurity

Agency Publication Date: March 30, 2020

Summary

Par Pharmaceutical Inc. is recalling 29,352 bottles of Glycopyrrolate (1 mg) tablets, a prescription medication used to treat conditions like peptic ulcers. This recall was initiated because testing detected the presence of an unknown impurity or degradation product that does not meet safety specifications. The affected product consists of 100-count bottles that were distributed throughout the United States.

Risk

The presence of an unidentified impurity means the medication does not meet established quality and safety standards, which could potentially cause unexpected side effects or reduce the effectiveness of the treatment.

What You Should Do

Check your medication bottle to see if it is Glycopyrrolate Tablets, USP 1 mg, in a 100-count bottle with NDC# 49884-0065-01.
Verify the lot number and expiration date on the label; the affected product is Lot # 32809101 with an expiration date of 3/2021.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on continued use and to obtain a replacement prescription.
Return any unused tablets from the affected lot to your pharmacy to receive a refund.
Contact Par Pharmaceutical Inc. at their Chestnut Ridge, NY office or through their customer service channels if you have specific questions regarding this recall.
For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Glycopyrrolate Tablets, USP 1 mg (100-count bottle)

Model:

NDC# 49884-0065-01

Recall #: D-1071-2020

Lot Numbers:

32809101 (Exp 3/2021)

Date Ranges: Expiration Date: 3/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85333

Status: Resolved

Manufacturer: Par Pharmaceutical Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 29,352 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle to see if it is Glycopyrrolate Tablets, USP 1 mg, in a 100-count bottle with NDC# 49884-0065-01.

Verify the lot number and expiration date on the label; the affected product is Lot # 32809101 with an expiration date of 3/2021.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on continued use and to obtain a replacement prescription.

Return any unused tablets from the affected lot to your pharmacy to receive a refund.

Contact Par Pharmaceutical Inc. at their Chestnut Ridge, NY office or through their customer service channels if you have specific questions regarding this recall.

For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.