Bayer Recalls Midol Complete Due to Labeling Mismatch
Bayer is recalling 119,412 cartons of Midol Complete because the blister strip label does not match the carton regarding the maximum daily dose.
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 by definition is unlikely to cause adverse health consequences. The issue is a labeling mismatch, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Bayer Healthcare, LLC is recalling 119,412 cartons of Midol Complete Gelcaps, 24 ct. blister, OTC. The recall was initiated after the company identified a labeling discrepancy where the statement on the blister strip regarding the maximum number of capsules or caplets to be taken within a 24-hour period does not match the statement on the carton.
The affected product is distributed to 93 retail accounts and customers. The specific lot codes involved are NAA04K6, NAA055P, and NAA05PA, all with an expiration date of 09/13. The National Drug Code (NDC) for the product is 0280-8015-24.
Consumers should check their Midol Complete products for these specific lot codes and expiration dates. If the product matches the recalled description, consumers should stop using it and contact Bayer Healthcare for further instructions or a refund.
The recalled product
- Product
- MIDOL COMPLETE (MIDOL COMPLETE)
- Brand
- MIDOL COMPLETE
- Manufacturer
- Bayer Healthcare, LLC
- Category
- Drug — OTC Pain Relief
- Hazard
- Affected units
- 119,412
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)
- NAA04K6 Exp. 09/13
- NAA055P Exp. 09/13
- NAA05PA Exp. 09/13
UPCs (1)
- 0312843172531
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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