CLASS II ONGOING Drug recall · Reported 30 Jul 2025 · FDA Enforcement Report
Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, distributed in Florida, Virginia. The recall was initiated on 21 Apr 2025 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-0538-2025
- FDA event ID
- 97110
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Brand
- Prolia
- Manufacturer
- Amgen, Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2025
- FDA classified
- 21 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Apr 2025 | Recall initiated by company | |
| 21 Jul 2025 | Classified by FDA | +91 days |
| 30 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; potential temperature excursions due to transit delays
Product as listed by the FDA
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Where it was distributed
Within the U.S - OH, VA, FL.
Questions about this recall
Why was it recalled?
CGMP Deviations; potential temperature excursions due to transit delays
Which lots are affected?
Lot: 1180924, Expiration date: 6/30/2027.
Where was it sold?
Within the U.S - OH, VA, FL.
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.
Other products in this recall event
2 other products · FDA event 97110This product is part of a recall event; the main page for the event is Evenity, (romosozumab -aqqg) injection, 105mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA | |
| CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
All 276| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled | Mckesson Medical-Surgical Inc. Corporate Office | Other | Nationwide |
| Drug | CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
| Device | CLASS II | Bd Microbiology Mac Conkey Ii Agar 21270 Media recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
Other Denosumab recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prolia (denosumab) Injection, 60 mg/mL recalled by AmgenProlia | Amgen | Particulate Matter | Nationwide |