Food, drugs, devices › Bayer HealthCare Pharmaceuticals Inc.

Drug recall: Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (l

FDA enforcement event 65702 · Class III · initiated 13 Jun 2013 · status Terminated · terminated 10 Feb 2014

DrugVoluntary: Firm initiated1 product recordMorristown, NJ

FDA enforcement event 65702 is a drug recall by Bayer HealthCare Pharmaceuticals Inc. of Morristown, NJ, initiated 13 Jun 2013 and classified Class III, with 1 product record.

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. 26% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 10 Feb 2014. 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., Morristown, NJ.

Reason for recall

"Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point."

Distribution

"NY, CA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-807-2013	Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin	194.62 kg	Class III	Terminated	24 Jul 2013

Context

26%of 2013 drug events are Class III370 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
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: "Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test 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: "NY, CA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Feb 2014. "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.