Drug recall: Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East…

Class III FDA enforcement event 92379. Recall start date: 18 May 2023. Status in the FDA record: Terminated. Termination date: 28 Aug 2024.

Reason for recall, in the words of FDA

Failed Impurities/Degradation Specifications

Class III, in the words of FDA

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

Aurolife Pharma, LLC started this drug recall on 18 May 2023. The firm address in the FDA record is in Dayton, NJ. FDA put the recall in Class III. FDA event 92379 has 1 product record. The first FDA enforcement report date is 28 Jun 2023. The record gives the status Terminated, with the termination date 28 Aug 2024.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide within the United States

Recalling firm

Aurolife Pharma, LLC, Dayton, NJ.

Recalling firm: The firm that the FDA record names for a recall.

Products

1 product record in the event.

FDA event 92379: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0877-2023	Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01		Class III	Terminated	28 Jun 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2023: 281
Share of these events in Class III: 26%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 4

Other events of the firm

Other FDA enforcement events of Aurolife Pharma, LLC
Initiated	Product (first record)	Type	Class	Records
16 Dec 2022	Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08	Drug	Class II	1
17 Mar 2022	Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-	Drug	Class II	1
23 Aug 2019	Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike,	Drug	Class II	11

Aurolife Pharma, LLC: all 4 events

Official channels

FDA enforcement report D-0877-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 92379. https://recallregister.com/fda/iii/92379/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide within the United States
How many drug recalls of 2023 have the same class?: 26% of the 281 drug events that started in 2023 are in Class III.
How many FDA recalls does Aurolife Pharma, LLC have?: Aurolife Pharma, LLC is the recalling firm in 4 enforcement events on this register. This event is 1 of them.