Trulicity — Class II drug recall D-0773-2021
Terminated recall by Eli Lilly & Company, reported 2021-09-01, distributed nationwide. Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain
| Recall number | D-0773-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eli Lilly & Company, Indianapolis, IN, United States |
| Recall initiated | 2021-08-19 |
| Classified | 2021-08-26 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2023-08-07 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 00002-1433, 00002-1433-01, 00002-1433-61, 00002-1433-80, 00002-1434, 00002-1434-01, 00002-1434-61, 00002-1434-80, 00002-2236, 00002-2236-01, 00002-2236-61, 00002-2236-80, 00002-3182, 00002-3182-01, 00002-3182-61, 00002-3182-80 |
| Lot numbers | D396436C |
Product
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Reason for recall
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
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-0773-2021. 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.