Acetaminophen tablets incorrectly labeled with aspirin drug facts information
Some bottles of Acetaminophen Extra Strength 500 mg tablets are labeled with the drug facts information for Aspirin 81 mg tablets. The affected lot is 4138197 (expiration 10/31/2025), distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls carry a minimum severity score of 4. Although no illnesses or injuries have been reported, mislabeling a pharmaceutical product as a different medication presents a significant patient safety concern.
Plain-English summary
A-S Medication Solutions LLC is recalling 429 bottles of Acetaminophen Extra Strength 500 mg tablets due to a labeling error. Some bottles contain acetaminophen but are labeled with the drug facts label intended for Aspirin 81 mg tablets. The affected lot is 4138197 with an expiration date of 10/31/2025, manufactured in Libertyville, Illinois.
This labeling error presents a patient safety concern because acetaminophen and aspirin are different medications. A consumer who unknowingly uses the mislabeled product may ingest the wrong medication, potentially resulting in improper treatment or harmful drug interactions with other medications.
The affected product was distributed nationwide in the United States. Consumers who have purchased Acetaminophen Extra Strength 500 mg tablets from lot 4138197 should discontinue use and contact A-S Medication Solutions LLC for instructions on return or disposal.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- A-S Medication Solutions LLC
- Category
- Drug — OTC Oral Tablets
- Hazard
- Affected units
- 429
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: 4138197
- Exp 10/31/2025
Distribution
Distributed nationwide across the United States.
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