drugs MODERATE Updated 2025-07-30

Mckesson Medical-Surgical Inc. Corporate Office recalls PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use

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Recalled Product

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

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Hazard / Issue

CGMP Deviations; potential temperature excursions due to transit delays

Issued by

FDA

Affected States: OH, VA, FL
Lot/Code Info: Lot: 1180924, Expiration date: 6/30/2027.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall