Glycopyrrolate Tablets — Class II drug recall D-0091-2023
Completed recall by AVKARE LLC, reported 2023-01-04, distributed nationwide. Failed impurities/degradation specifications: Out of specification for unknown impurities.
| Recall number | D-0091-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE LLC, Pulaski, TN, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2022-12-28 |
| Reported by FDA | 2023-01-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,237 cartons |
| Reason classes | specification failure |
| NDC | 50268-0363, 50268-0363-11, 50268-0363-15 |
| Lot numbers | 43313, 43342 |
| Expiration dates | 2023-12 |
Product
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
Reason for recall
Failed impurities/degradation specifications: Out of specification for unknown impurities.
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-0091-2023. 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.