CLASS III Drug recall · Reported 25 Jul 2012 · FDA Enforcement Report
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate recalled
Bayer Healthcare is recalling Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps blister. The recall was initiated on 26 Apr 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1423-2012
- FDA event ID
- 61948
- Recalling firm
- Bayer Healthcare, Morristown, NJ
- Brand
- Midol Complete
- Manufacturer
- Bayer HealthCare LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Apr 2012
- FDA classified
- 19 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 26 Apr 2012 | Recall initiated by company | |
| 19 Jul 2012 | Classified by FDA | +84 days |
| 25 Jul 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24
Where it was distributed
Product was distributed to 93 retail accounts/customers.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13
Where was it sold?
Product was distributed to 93 retail accounts/customers.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 61948| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets recalledMidol Complete | Bayer Healthcare | Packaging Defects | NJ |
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