The Recall Desk
HighFDA (Drugs)·D-0884-2022·Announced 2022-05-25

TRULICITY Dulaglutide Injection Recalled for Temperature Abuse During Distribution

Cardinal Health Inc. recalls one lot of TRULICITY (dulaglutide) injection due to temperature abuse. The product was exposed to temperatures outside the manufacturer's labeled storage conditions.

What this means for you

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 is an FDA Class II recall for temperature-compromised medication. While no illnesses or injuries have been reported, temperature abuse of an injectable prescription drug represents a risk of harm, as the medication may be degraded or ineffective.

Plain-English summary

Cardinal Health Inc. is recalling one lot of TRULICITY (dulaglutide) injection, 0.75 mg/0.5mL, in 4 single-dose pens. The product was exposed to temperatures outside the manufacturer's labeled storage conditions.

The affected lot number is D484557A with an expiration date of 10/25/2023. Distribution was limited to New Mexico. TRULICITY is a once-weekly injectable prescription medication.

The FDA classified this as a Class II recall and assigned recall number D-0884-2022. Patients who received this lot should contact their healthcare provider or pharmacy regarding the recalled product.

The recalled product

Product
TRULICITY (DULAGLUTIDE)
Brand
TRULICITY
Manufacturer
Cardinal Health Inc.
Category
Drug
Hazard
  • temperature-abuse

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 #: D484557A
  • Exp: 10/25/2023.

Distribution

Distributed in 1 state:

  • NM

Same brand · TRULICITY