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.
What this means for you
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
- product-impurity
- product-degradation
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.
Related recalls
Same brand · GLYCOPYRROLATE
- ModerateGlycopyrrolate Oral Solution Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-02-04
- ModerateGlycopyrrolate Injection Vials Recalled Due to Labeling Mix-up
FDA (Drugs) · 2023-06-14
- ModerateGlycopyrrolate injection recalled due to manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- HighGlycopyrrolate Injection Recalled Due to Manufacturing Quality Deviations
FDA (Drugs) · 2023-03-08
- HighPrescription Glycopyrrolate Injection Recalled Due to Manufacturing Process Deviations
FDA (Drugs) · 2023-03-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27