Mckesson Medical-Surgical Inc. Corporate Office Evenity Recall

Why it was recalled

CGMP Deviations; potential temperature excursions due to transit delays

Product description

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.

Lot numbers, UPCs & expiration codes

Lot: 1178382, Expiration date: 3/31/2027

Where it was sold

Within the U.S - OH, VA, FL.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0539-2025
Classification: Class II
Status: Ongoing
Recall initiated: Apr 21, 2025
FDA report date: Jul 30, 2025
Quantity: 2 Pre-filled syringes
Recall type: Voluntary: Firm initiated
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office

Original FDA data

Every field from FDA enforcement report D-0539-2025, exactly as published.

Show all FDA fields

City: Richmond
State: VA
Status: Ongoing
Country: United States
Event ID: 97110
Address: 9954 Maryland Drive
Address (line 2): Deep Run Iii Ste. 4000
Code information: Lot: 1178382, Expiration date: 3/31/2027
Postal code: 23233
Report date: Jul 30, 2025
Product type: Drugs
Recall number: D-0539-2025
Classification: Class II
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Product quantity: 2 Pre-filled syringes
Reason for recall: CGMP Deviations; potential temperature excursions due to transit delays
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Within the U.S - OH, VA, FL.
Recall initiation date: Apr 21, 2025
Initial firm notification: Letter
Center classification date: Jul 21, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0539-2025, published Jul 30, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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