The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0883-2022·Announced 2022-05-25

Trulicity Injection Recalled Due to Temperature Exposure During Shipment

A batch of Trulicity (dulaglutide) injection was recalled due to temperature exposure during distribution in New Mexico. The product was exposed to temperatures outside its labeled storage requirements due to inclement weather.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall meets the 'High' severity criterion as a risk-of-harm pharmaceutical product with no reported illnesses, injuries, or deaths. Per the severity rubric, recalls with theoretical hazards and no reported patient harm are limited to a maximum of High.

Plain-English summary

Cardinal Health Inc. is recalling a batch of Trulicity (dulaglutide) injection due to temperature exposure. The affected product is Trulicity injection, 1.5 mg/0.5 mL, supplied as 4 single-dose pens per package, with lot number D482749A and expiration date of 10/15/2023.

The product was exposed to temperatures outside the manufacturer's labeled storage conditions due to inclement weather during distribution. This recall affects products distributed in New Mexico only.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80
Manufacturer
Cardinal Health Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: D482749A
  • Exp: 10/15/2023.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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