Medline Acetaminophen Tablets Recalled for Incorrect Strength Labeling
Medline Industries is recalling 325 mg acetaminophen tablets that are actually 500 mg due to a labeling error.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Medline Industries, Inc. is recalling specific bottles of Acetaminophen Regular-Strength Pain Reliever tablets. The recall involves 100-count bottles labeled as containing 325 mg tablets, but which actually contain 500 mg tablets. The affected product is identified by NDC 53329-642-30, Lot # 45810, and an expiration date of 05/18.
The recall was initiated because of a labeling error where the declared strength on the bottle did not match the actual tablet strength. This discrepancy could lead to consumers taking a higher dose of acetaminophen than intended if they follow the dosing instructions for the 325 mg strength.
The product was distributed nationwide. Consumers who have this specific product should stop using it and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
- Manufacturer
- Medline Industries Inc
- Hazard
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 (2)
- lot # 45810
- Exp. 05/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medline Industries Inc 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.
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