Recall archive / FDA drug enforcement

Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ... — FDA record D-0087-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Reason: Failed Impurities/Degradation Specifications
Classification: Class II
Recalling firm: Aurolife Pharma, LLC
Quantity: 7344 bottles
Agency-reported status: Ongoing
Source record identifier: D-0087-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA and Puerto Rico.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Dec 28, 2022
Recall initiation date: Dec 16, 2022
Center classification date: Dec 22, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.