CLASS II Drug recall · Reported 1 Sep 2021 · FDA Enforcement Report
Trulicity (dulaglutide), 0.75 mg/-Dose Pens recalled by Eli Lilly &
Eli Lilly is recalling Trulicity (dulaglutide), 0.75 mg/-Dose Pens per, distributed nationwide in the US. The recall was initiated on 19 Aug 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0773-2021
- FDA event ID
- 88505
- Recalling firm
- Eli Lilly, Indianapolis, IN
- Brand
- Trulicity
- Manufacturer
- Eli Lilly and Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2021
- FDA classified
- 26 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 19 Aug 2021 | Recall initiated by company | |
| 26 Aug 2021 | Classified by FDA | +7 days |
| 1 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot number: D396436C
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Zyprexa Intramuscular, Olanzapine for Injection recalled by Eli Lilly & | Eli Lilly | Manufacturing (CGMP) Deviations | IN, MS, OH |
| Drug | CLASS III | Erbitux Cetuximab Injection, 200 mg/ (2 mg/mL) per single-use vial recalledErbitux | Eli Lilly | Labeling Errors | 11 states |
Other Dulaglutide recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trulicity (dulaglutide) injection, 0.75 mg/ once weekly-Dose Pens recalledTrulicity | Cardinal Health | Temperature Abuse | NM |