Lower risk Drug recall · FDA · Published April 21, 2025

EVENITY Injection Recall: Potential Temperature Issues During Transit

Mckesson Medical-Surgical recalls EVENITY (romosozumab) injections due to possible temperature excursions during shipping. Affected lots may have been exposed to temperatures outside safe ranges, risking product stability.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0539-2025Drug Mckesson Medical-Surgical ›

Lower-risk recall

CGMP Deviations; potential temperature excursions due to transit delays

Take action

Contact the company

Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233

✎ GovInfoNow plain-language explainer

Mckesson Medical-Surgical is recalling EVENITY injections (105mg/1.17 mL) that may have experienced temperature issues during shipping. This could affect product stability and safety for patients using the medication. Read more at govinfonow.com/recall/32124-evenity-injection-recall-potential-temperature-issues-during-transit.

Source Summary by GovInfoNow · govinfonow.com/recall/32124-evenity-injection-recall-potential-temperature-issues-during-transit · Updated August 17, 2026 · FDA enforcement record: FDA #D-0539-2025

Cite this page

“EVENITY Injection Recall: Potential Temperature Issues During Transit.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32124-evenity-injection-recall-potential-temperature-issues-during-transit. Based on FDA recall #D-0539-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0539-2025%22&limit=1).

The FDA announced on April 21, 2025, that Mckesson Medical-Surgical Inc. Corporate Office is recalling EVENITY (romosozumab-aqqg) injection due to potential temperature excursions from transit delays. The recall affects lots manufactured by Amgen Inc.

How to tell if you have it

Brand: Mckesson Medical-Surgical
Product: EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL
Lot: 1178382
Expiration date: 3/31/2027
NDC: 55513-880-02

The hazard

The recall is due to CGMP deviations and potential temperature excursions caused by transit delays. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has had 14 other recalls on record since June 2, 2021. Other recent recalls of similar products include McKesson Recalls UDENYCA Injection Due to Temperature Abuse Risk (Jan. 16, 2026) and McKesson Gemcitabine Injection Recall: Temperature Storage Risk (June 10, 2026).

How to tell if you have this one

Check the lot number on the product label. The affected lot is 1178382 with an expiration date of 3/31/2027. The product is manufactured by Amgen Inc. in Thousand Oaks, CA.

Brand
Mckesson Medical-Surgical
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Within the U.S - OH, VA, FL.

Recall number	Product, codes & lots	Quantity	NDC
D-0538-2025	PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21; Lot: 1180924, Expiration date: 6/30/2027.	6 Pre-filled syringes	55513-710-01, 55513-710-21
D-0539-2025	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: 1178382, Expiration date: 3/31/2027	2 Pre-filled syringes	55513-880-01, 55513-880-02, 55513-998-01, 55513-998-02, 55513-509-01, 55513-509-02
D-0540-2025	BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.; Lot: YK4W, Expiration date: 4/30/2029	3 Vials	49401-102-01, 49401-101-01, 49401-088-42, 49401-088-47, 49401-088-50, 49401-088-01, 49401-088-35, 49401-088-02, 49401-088-61

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot number 1178382 on the EVENITY injection label.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “Within the U.S - OH, VA, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Ohio, Virginia.

Recall timeline

FDA published this recall 3 months after the firm started it.

Apr 21, 2025Firm started the recall
Jul 21, 2025FDA classified it Class II
Jul 30, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32124-evenity-injection-recall-potential-temperature-issues-during-transit">EVENITY Injection Recall: Potential Temperature Issues During Transit (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0539-2025 (April 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0539-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.