The Recall Desk
HighFDA (Drugs)·D-0538-2025·Announced 2025-07-30

Drug recall: PROLIA denosumab due to manufacturing deviations and temperature issues

Mckesson is recalling PROLIA (denosumab) 60mg/mL pre-filled syringes (lot 1180924) due to CGMP manufacturing deviations and potential temperature excursions during transit in Ohio, Virginia, and Florida.

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 a biologic drug (risk-of-harm product) where manufacturing quality deviations and potential temperature instability have been identified. Although no illnesses or injuries have been reported, temperature excursions could compromise drug efficacy, warranting high severity as a preventive measure.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling PROLIA (denosumab) 60mg/mL pre-filled syringes due to identified CGMP deviations and potential temperature excursions during transit.

The affected lot is 1180924, which expires 6/30/2027 and was distributed in Ohio, Virginia, and Florida. The product is manufactured by Amgen Inc.

Potential temperature excursions during transit could affect product stability. Customers who received this lot should discontinue use and contact their supplier for instructions.

The recalled product

Product
PROLIA (DENOSUMAB)
Brand
PROLIA
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug
Hazard
  • cgmp-deviation
  • temperature-excursion

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: 1180924
  • Expiration date: 6/30/2027.

Distribution

Distributed in 3 states:

  • FL
  • OH
  • VA

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