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Drug FDA Class II Ongoing cGMP deviation

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Mckesson Medical-Surgical Inc. Corporate Office Published Jul 30, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Mckesson Medical-Surgical Inc. Corporate Office or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations; potential temperature excursions due to transit delays

Hazards

Temperature Excursion · primary

Affected products (1)

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

EVENITY · 2 Pre-filled syringes

NDC: 55513-509, 55513-880, 55513-998, 55513-880-01, 55513-880-02, 55513-998-01, 55513-998-02, 55513-509-01, 55513-509-02
Lot codes: 1178382
Code info: Lot: 1178382, Expiration date: 3/31/2027

Affected areas

FloridaOhioVirginia

Timeline

  1. Initiated
    Apr 21, 2025
  2. Published
    Jul 30, 2025
Recall number
D-0539-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.