Glycopyrrolate Tablets — Class III drug recall D-0877-2023
Terminated recall by Aurolife Pharma, LLC, reported 2023-06-28, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0877-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Recalling firm | Aurolife Pharma, LLC, Dayton, NJ, United States |
| Recall initiated | 2023-05-18 |
| Classified | 2023-06-20 |
| Reported by FDA | 2023-06-28 |
| Terminated | 2024-08-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 13107-0014, 13107-0014-01, 13107-0015, 13107-0015-01 |
| Lot numbers | 01421038A1 |
| Expiration dates | 2023-05 |
Product
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0877-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.