Drug recall: PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand…

Class II FDA enforcement event 97110. Recall start date: 21 Apr 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

CGMP Deviations; potential temperature excursions due to transit delays

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Mckesson Medical-Surgical Inc. Corporate Office started this drug recall on 21 Apr 2025. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 97110 has 3 product records. The first FDA enforcement report date is 30 Jul 2025. The record gives the status Ongoing.

FDA enforcement report The 3 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

3 product records in the event.

FDA event 97110: product records
Recall number	Product	Quantity	Class	Status	Report date
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	6 Pre-filled syringes	Class II	Ongoing	30 Jul 2025
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.	2 Pre-filled syringes	Class II	Ongoing	30 Jul 2025
D-0540-2025	BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.	3 Vials	Class II	Ongoing	30 Jul 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2025: 322
Share of these events in Class II: 79%
Product records in this event: 3Median of the firm: 3
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Mckesson Medical-Surgical Inc. Corporate Office
Initiated	Product (first record)	Type	Class	Records
30 Jul 2025	Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020	Device	Class II	1
25 Apr 2025	Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for:	Drug	Class II	2
24 Apr 2025	ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL	Device	Class II	32
17 Sep 2024	Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a con	Device	Class II	1
11 Sep 2024	Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and	Drug	Class II	1
11 Sep 2024	Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208	Drug	Class II	1
23 Apr 2024	Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Numbe	Device	Class II	1
7 Feb 2024	Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma L	Drug	Class II	3
9 Jan 2024	Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis	Device	Class II	5
29 Jun 2022	Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibio	Drug	Class II	17

Mckesson Medical-Surgical Inc. Corporate Office: all 15 events

Official channels

FDA enforcement report D-0538-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 97110. https://recallregister.com/fda/ii/97110/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Within the U.S - OH, VA, FL.
What quantity of product is in FDA event 97110?: The event has 3 product records. The first record gives this quantity: 6 Pre-filled syringes
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2025 have the same class?: 79% of the 322 drug events that started in 2025 are in Class II.