Food, drugs, devices › Bayer HealthCare Pharmaceuticals Inc.

Drug recall: Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, L

FDA enforcement event 62908 · Class III · initiated 31 May 2012 · status Terminated · terminated 10 May 2013

DrugVoluntary: Firm initiated1 product recordLynnwood, WA

Bayer HealthCare Pharmaceuticals Inc. (Lynnwood, WA) initiated this drug recall on 31 May 2012; FDA lists 1 product record under event 62908, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 28% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 10 May 2013. 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., Lynnwood, WA.

Reason for recall

"Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-156-2013	Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2	138,505 vials	Class III	Terminated	13 Feb 2013

Context

28%of 2012 drug events are Class III209 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
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
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: "Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 May 2013. "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.