Drug recall: VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare…

Class I FDA enforcement event 93391. Recall start date: 6 Nov 2023. Status in the FDA record: Terminated. Termination date: 29 May 2024.

Reason for recall, in the words of FDA

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Bayer Healthcare Pharmaceuticals Inc. started this drug recall on 6 Nov 2023. The firm address in the FDA record is in Whippany, NJ. FDA put the recall in Class I. FDA event 93391 has 1 product record. The first FDA enforcement report date is 6 Dec 2023. The record gives the status Terminated, with the termination date 29 May 2024.

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.

Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.

Recalling firm

Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ.

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 93391: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0145-2024	VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01	192 bottles	Class I	Terminated	6 Dec 2023

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 I: The highest of the three FDA recall classes.

The event in context

Drug events that started in 2023: 281
Share of these events in Class I: 15%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Bayer Healthcare Pharmaceuticals Inc.
Initiated	Product (first record)	Type	Class	Records
1 Oct 2021	LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whip	Drug	Class I	19
15 Mar 2018	All Alka-Seltzer Plus packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton.	Drug	Class I	1
23 Feb 2018	Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bo	Drug	Class II	1
10 Nov 2017	Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Mo	Drug	Class III	1
30 Mar 2017	Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric	Drug	Class II	3
21 Feb 2017	A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz	Drug	Class III	1
13 Jun 2013	Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (l	Drug	Class III	1
31 May 2012	Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, L	Drug	Class III	1
8 May 2012	Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Baye	Drug	Class II	1

Bayer Healthcare Pharmaceuticals Inc.: all 10 events

Official channels

FDA enforcement report D-0145-2024The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 93391. https://recallregister.com/fda/i/93391/. 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: Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
What quantity of product is in FDA event 93391?: The FDA record gives this quantity: 192 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2023 have the same class?: 15% of the 281 drug events that started in 2023 are in Class I.