Drug recall: Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx…

Class II FDA enforcement event 96637. Recall start date: 9 Apr 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.

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

Cardinal Health Inc. started this drug recall on 9 Apr 2025. The firm address in the FDA record is in Dublin, OH. FDA put the recall in Class II. FDA event 96637 has 1 product record. The first FDA enforcement report date is 7 May 2025. The record gives the status Ongoing.

FDA enforcement report The 1 product record

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.

NC, SC, VA

Recalling firm

Cardinal Health Inc., Dublin, OH.

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

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

Products

1 product record in the event.

FDA event 96637: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0393-2025	Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.	48 Cartons	Class II	Ongoing	7 May 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: 1Median of the firm: 3
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Cardinal Health Inc.
Initiated	Product (first record)	Type	Class	Records
5 Aug 2025	Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 pref	Drug	Class II	1
30 Jul 2025	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5	Drug	Class II	3
31 Oct 2023	LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL	Drug	Class I	6
5 Apr 2022	Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA	Drug	Class I	3
16 Mar 2021	FREESTYLE LANCETS 28G 100CT Item Number:2975670	Device	Class II	14
15 Mar 2021	THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS	Drug	Class II	198
9 Mar 2021	Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janss	Drug	Class III	1
20 Apr 2020	B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of	Device	Class II	3
26 Dec 2019	Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100	Device	Class II	6
14 Nov 2019	S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-	Device	Class II	3

Cardinal Health Inc.: all 12 events

Official channels

FDA enforcement report D-0393-2025The 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 96637. https://recallregister.com/fda/ii/96637/. 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: NC, SC, VA
What quantity of product is in FDA event 96637?: The FDA record gives this quantity: 48 Cartons
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.