Esomeprazole Magnesium Delayed-Release Capsules — Class II drug recall D-0860-2022
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2022-05-18, distributed nationwide. Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the
| Recall number | D-0860-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-05-11 |
| Reported by FDA | 2022-05-18 |
| Terminated | 2023-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 555 cartons |
| Reason classes | specification failure |
| NDC | 42292-0009-16 |
| Lot numbers | 3110438, 3111120, 3111708, 3112582, 3112743 |
| Expiration dates | 2022-07-31, 2023-03-31, 2023-04-30 |
Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 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 42292-009-16
Reason for recall
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
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-0860-2022. 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.