FDA Drug recall D-1424-2012
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distribu…
- FDA Drug
- Class III
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class III recall of Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distribu… by Bayer Healthcare, citing 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 t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1424-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-04-26 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bayer Healthcare |
| Distribution | n/a |
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
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.
Identifiers
| ndc | 0280-8005-16 |
|---|---|
| ndc | 0280-8005-24 |
| ndc | 0280-8005-40 |
| ndc | 0280-8005-01 |
| ndc | 0280-8005-02 |
| ndc | 0280-8005-04 |
| ndc | 0280-8005-25 |
| code_info | NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1424-2012%22
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