Bayer Recalls Midol Complete Due to Labeling Mismatch
Bayer Healthcare is recalling 48,528 cartons of Midol Complete because the maximum daily dose stated on the blister strip does not match the carton label.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a minor labeling error.
Plain-English summary
Bayer Healthcare, LLC is recalling 48,528 cartons of Midol Complete (Acetaminophen, Caffeine, and Pyrilamine Maleate) caplets. The recall was initiated after the company identified a labeling discrepancy where the statement on the blister strip regarding the maximum number of caplets to be taken within a 24-hour period does not match the statement on the carton.
The affected product includes 16-count and 24-count blister packs distributed to 93 retail accounts and customers. The specific lot codes involved are NAA055N, NAA05PC, and NAA0462, all with an expiration date of 12/13.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE)
- Brand
- MIDOL COMPLETE
- Manufacturer
- Bayer Healthcare, LLC
- Category
- Drug — OTC Pain Reliever
- Hazard
- Affected units
- 48,528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- NAA055N Exp.12/13
- NAA05PC Exp.12/13
- NAA0462 Exp.12/13
UPCs (1)
- 0312843555198
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Bayer Healthcare, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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