Recall Register

Food, drugs, devices › Firms

Bayer Healthcare, LLC

FDA recalling firm · 4 enforcement events · 5 product records · 2012–2015 · NJ, CA

Bayer Healthcare, LLC has 4 FDA enforcement events on this register (5 product records) between 2012 and 2015: 2 device and 2 drug; the busiest year was 2012 with 2.

0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in NJ and CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
22 Jun 2015Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.DeviceClass II1Terminated
26 Aug 2013Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or…DeviceClass II1Terminated
7 Dec 2012Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962.DrugClass III1Terminated
26 Apr 2012Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24DrugClass III2Terminated

By type and class

Device2
Drug2
Class II2
Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Bayer Healthcare, LLC by year initiated.

Questions and answers

How many FDA recalls has Bayer Healthcare, LLC had?

4 enforcement events (5 product records) on this register, 2012–2015: 2 device, 2 drug.

Are any Bayer Healthcare, LLC recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Bayer Healthcare, LLC recalls?

2 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.