The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0877-2023·Announced 2023-06-28

Glycopyrrolate Tablets Recalled Due to Failed Impurities and Degradation Specifications

Aurolife Pharma has recalled Glycopyrrolate Tablets (1 mg) nationwide due to failed impurity and degradation specifications. Affected lot 01421038A1 expires May 2023.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall, the agency's least serious classification, involving failed impurity and degradation specifications. No illnesses or injuries are reported in the source material, and the FDA has determined that use of this violative product is unlikely to result in adverse health consequences.

Plain-English summary

Aurolife Pharma, LLC is recalling Glycopyrrolate Tablets, USP, 1 mg in 100-count bottles (NDC 13107-014-01), distributed by Aurobindo Pharma USA, Inc. The product was distributed nationwide.

The recall was initiated because the tablets failed to meet impurity and degradation specifications. This means the product may contain impurities above acceptable levels or show degradation in its chemical composition.

The affected lot is 01421038A1, with an expiration date of May 2023. Consumers and healthcare providers should stop using tablets from this lot and consult with a pharmacist or doctor about obtaining an alternative supply.

For more information, contact the FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls or refer to FDA recall number D-0877-2023.

The recalled product

Product
GLYCOPYRROLATE (GLYCOPYRROLATE)
Brand
GLYCOPYRROLATE
Manufacturer
Aurolife Pharma, LLC
Category
Drug — Prescription Tablet
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 01421038A1
  • Exp. Date 05/2023

UPCs (1)

  • 0313107014017

Distribution

Distributed nationwide across the United States.

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