Drug recall: Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E.…

Class II FDA enforcement event 95146. Recall start date: 15 Aug 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility

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

Fagron Compounding Services started this drug recall on 15 Aug 2024. The firm address in the FDA record is in Wichita, KS. FDA put the recall in Class II. FDA event 95146 has 1 product record. The first FDA enforcement report date is 28 Aug 2024. 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.

Nationwide in the USA

Recalling firm

Fagron Compounding Services, Wichita, KS.

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 95146: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0636-2024	Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.		Class II	Ongoing	28 Aug 2024

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 2024: 319
Share of these events in Class II: 71%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 6

Other events of the firm

Other FDA enforcement events of Fagron Compounding Services
Initiated	Product (first record)	Type	Class	Records
20 Mar 2026	norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. W	Drug	Class II	5
20 Nov 2025	Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe	Drug	Class II	1
29 Aug 2025	bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 871	Drug	Class II	1
31 Jan 2025	fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services,	Drug	Class II	1
10 Nov 2023	Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottl	Drug	Class III	1

Fagron Compounding Services: all 6 events

Official channels

FDA enforcement report D-0636-2024The 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 95146. https://recallregister.com/fda/ii/95146/. 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: Nationwide in the USA
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2024 have the same class?: 71% of the 319 drug events that started in 2024 are in Class II.
How many FDA recalls does Fagron Compounding Services have?: Fagron Compounding Services is the recalling firm in 6 enforcement events on this register. This event is 1 of them.