FDA Drug recall D-0091-2023
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15
- FDA Drug
- Class II
- completed
- Published 2023-01-04
On 2023-01-04 the FDA classified a Class II recall of Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15 by Avkare, citing failed impurities/degradation specifications: Out of specification for unknown impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0091-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-12-22 |
| Published | 2023-01-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
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
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Identifiers
| ndc | 50268-363-11 |
|---|---|
| ndc | 50268-363-15 |
| code_info | Lot#: 43313, 43342, Exp 12/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0091-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.