Food, drugs, devices › Bayer HealthCare Pharmaceuticals, Inc.

Drug recall: Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bo

FDA enforcement event 79252 · Class II · initiated 23 Feb 2018 · status Terminated · terminated 9 Jan 2020

DrugVoluntary: Firm initiated1 product recordWhippany, NJ

Bayer HealthCare Pharmaceuticals, Inc. (Whippany, NJ) initiated this drug recall on 23 Feb 2018; FDA lists 1 product record under event 79252, classified Class II.

FDA defines Class II as 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 9 Jan 2020. Initiation: voluntary: firm initiated. Bayer HealthCare Pharmaceuticals, Inc. has 10 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ.

Reason for recall

"Labeling: Label mix-up"

Distribution

"Arkansas only"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0590-2018	Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.	528 units	Class II	Terminated	14 Mar 2018

Context

60%of 2018 drug events are Class II367 events that year

1product record in this eventfirm median: 1

10events on this register for the firm

Other enforcement events for Bayer HealthCare Pharmaceuticals, Inc.

Initiated	Product (first record)	Type	Class	Records
6 Nov 2023	VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutica	Drug	Class I	1
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
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

All 10 events for Bayer HealthCare Pharmaceuticals, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Label mix-up"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Arkansas only"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 9 Jan 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.