Food, drugs, devices › Bayer Healthcare, LLC
Drug recall: Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Ca
FDA enforcement event 61948 is a drug recall by Bayer Healthcare, LLC of Morristown, NJ, initiated 26 Apr 2012 and classified Class III, with 2 product records.
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 27 Mar 2014. Initiation: voluntary: firm initiated. Bayer Healthcare, LLC has 4 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, LLC, Morristown, NJ.
Reason for recall
"Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton."
Distribution
"Product was distributed to 93 retail accounts/customers."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1423-2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 | 119,412 cartons | Class III | Terminated | 25 Jul 2012 |
| D-1424-2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25) | 48,528 cartons | Class III | Terminated | 25 Jul 2012 |
Context
Other enforcement events for Bayer Healthcare, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Jun 2015 | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottl | Device | Class II | 1 |
| 26 Aug 2013 | Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated He | Device | Class II | 1 |
| 7 Dec 2012 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caple | Drug | Class III | 1 |
All 4 events for Bayer Healthcare, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton."
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: "Product was distributed to 93 retail accounts/customers."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Mar 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.