FDA Drug recall D-0861-2022
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carto…
- FDA Drug
- Class II
- terminated
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carto… by Mylan Institutional D B A Udl Laboratories, citing failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0861-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-01 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
Reason
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Identifiers
| code_info | Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0861-2022%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.