Medline Recalls Mislabeled Acetaminophen Extra-Strength Pain Reliever Tablets
Medline Industries is recalling 500 mg acetaminophen tablets mislabeled as 325 mg. Consumers should stop using the product and return it to the retailer.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) because they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medline Industries, Inc. is recalling 7,372 bottles of Acetaminophen Extra-Strength Pain Reliever tablets, 500 mg, 100-count. The product is distributed nationwide under NDC 53329-641-30. The specific lot affected is # 45810 with an expiration date of 05/18.
The recall was initiated due to a labeling error. Bottles containing 500 mg acetaminophen tablets were mislabeled to indicate they contain 325 mg tablets. This discrepancy could lead to consumers taking an incorrect dosage of the medication.
Consumers who have purchased this product should stop using it immediately. They should return the product to the place of purchase for a refund or contact Medline Industries for further instructions. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
The recalled product
- Product
- ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 7,372
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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