Midol Complete — Class III drug recall D-1424-2012
Terminated recall by Bayer Healthcare, LLC, reported 2012-07-25. Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister st
| Recall number | D-1424-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, LLC, Morristown, NJ, United States |
| Recall initiated | 2012-04-26 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2014-03-27 |
| Quantity | 48,528 cartons |
| Reason classes | labeling |
| NDC | 00280-8005, 00280-8005-01, 00280-8005-02, 00280-8005-04, 00280-8005-16, 00280-8005-24, 00280-8005-25, 00280-8005-40 |
Product
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)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1424-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.