FDA Drug recall D-0773-2021
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-…
- FDA Drug
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of 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-… by Eli Lilly And, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0773-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-19 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eli Lilly And |
| Distribution | US |
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
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.
Identifiers
| ndc | 0002-1433-01 |
|---|---|
| ndc | 0002-1433-80 |
| ndc | 0002-1433-61 |
| ndc | 0002-1434-01 |
| ndc | 0002-1434-80 |
| ndc | 0002-1434-61 |
| ndc | 0002-2236-01 |
| ndc | 0002-2236-80 |
| ndc | 0002-2236-61 |
| ndc | 0002-3182-01 |
| ndc | 0002-3182-80 |
| ndc | 0002-3182-61 |
| code_info | Lot number: D396436C |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0773-2021%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.