Medications & Supplements/Prescription Drugs

Prolia, Evenity, and Benlysta Recalled for Potential Temperature Exposure

Agency Publication Date: July 21, 2025

Summary

McKesson Medical-Surgical Inc. has recalled 11 units of Prolia (denosumab), Evenity (romosozumab-aqqg), and Benlysta (belimumab) injection medications. The recall was initiated because shipping delays may have exposed these products to temperatures outside of their required range. The affected products include 6 syringes of Prolia, 2 syringes of Evenity, and 3 vials of Benlysta.

Risk

These medications are sensitive to heat and must be kept at specific temperatures to remain effective. Potential temperature excursions due to transit delays could reduce the effectiveness of the drug or compromise its safety. No injuries or illnesses have been reported to date.

What You Should Do

This recall affects Prolia (denosumab) syringes (Lot 1180924, Exp 6/30/2027), Evenity (romosozumab-aqqg) syringes (Lot 1178382, Exp 3/31/2027), and Benlysta (belimumab) vials (Lot YK4W, Exp 4/30/2029).
Check your medication packaging for the brand name and the specific lot numbers and expiration dates listed above to determine if your product is included in this recall.
If you have health concerns about using these medications, contact your healthcare provider or pharmacist immediately.
Return any unused recalled product to the place of purchase for a refund, throw it away, or contact McKesson Medical-Surgical Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PROLIA (denosumab) injection (60mg/mL)

Variants: 60mg/mL, Pre-filled syringe

Lot Numbers:

1180924 (Exp 6/30/2027)

NDC:

55513-710-21

Manufactured by Amgen Inc.

Product: EVENITY (romosozumab-aqqg) injection (105mg/1.17 mL)

Variants: 105mg/1.17 mL, Pre-filled syringe

Lot Numbers:

1178382 (Exp 3/31/2027)

NDC:

55513-880-02

Manufactured by Amgen Inc.

Product: BENLYSTA (belimumab) for injection (400 mg/20 mL)

Variants: 400 mg/20 mL, Vial

Lot Numbers:

YK4W (Exp 4/30/2029)

NDC:

49401-102-01

Manufactured by GSK

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97110

Status: Active

Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office

Sold By: McKesson Medical-Surgical Inc.

Manufactured In: United States

Units Affected: 3 products (6 Pre-filled syringes; 2 Pre-filled syringes; 3 Vials)

Distributed To: Ohio, Virginia, Florida

Agency Last Updated: July 29, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Prolia (denosumab) syringes (Lot 1180924, Exp 6/30/2027), Evenity (romosozumab-aqqg) syringes (Lot 1178382, Exp 3/31/2027), and Benlysta (belimumab) vials (Lot YK4W, Exp 4/30/2029).

Check your medication packaging for the brand name and the specific lot numbers and expiration dates listed above to determine if your product is included in this recall.

If you have health concerns about using these medications, contact your healthcare provider or pharmacist immediately.

Return any unused recalled product to the place of purchase for a refund, throw it away, or contact McKesson Medical-Surgical Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: PROLIA (denosumab) injection (60mg/mL)

Variants: 60mg/mL, Pre-filled syringe

Lot Numbers:

1180924 (Exp 6/30/2027)

NDC:

55513-710-21

Manufactured by Amgen Inc.

Product: EVENITY (romosozumab-aqqg) injection (105mg/1.17 mL)

Variants: 105mg/1.17 mL, Pre-filled syringe

Lot Numbers:

1178382 (Exp 3/31/2027)

NDC:

55513-880-02

Manufactured by Amgen Inc.

Product: BENLYSTA (belimumab) for injection (400 mg/20 mL)

Variants: 400 mg/20 mL, Vial

Lot Numbers:

YK4W (Exp 4/30/2029)

NDC:

49401-102-01

Manufactured by GSK

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97110

Status: Active

Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office

Sold By: McKesson Medical-Surgical Inc.

Manufactured In: United States

Units Affected: 3 products (6 Pre-filled syringes; 2 Pre-filled syringes; 3 Vials)

Distributed To: Ohio, Virginia, Florida

Agency Last Updated: July 29, 2025