Acetaminophen Extra Strength tablets recalled for incorrect enteric-coated labeling
LNK International is recalling Acetaminophen Extra Strength coated tablets because the primary label incorrectly states "enteric coated" when the tablets are not enteric coated and should be labeled as standard coated tablets.
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: This is an FDA Class III recall involving a labeling inaccuracy with no reported illnesses or injuries. The hazard is a documentation/labeling error rather than a safety defect in the product formulation, which aligns with the "Low" category for labeling or documentation issues.
Plain-English summary
LNK International, Inc. is recalling Acetaminophen Extra Strength Pain Reliever / Fever Reducer coated tablets (500 mg, 50-tablet bottles, NDC 46122-649-71, Lot # P120999, Exp 07/31/2022) distributed by AmerisourceBergen. The reason for the recall is labeling inaccuracy: the primary label contains the words "enteric coated," but the tablets are not enteric coated and should only be labeled as "coated tablet."
This is a labeling classification issue. Consumers who have purchased affected bottles should note the discrepancy between the label description and the actual product formulation.
No further details regarding specific health risks or injury reports are provided in the source material.
The recalled product
- Product
- Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
- Manufacturer
- LNK International, Inc.
- Hazard
- Affected units
- 8,472
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 # P120999
- Exp 07/31/2022
Distribution
Distributed in 1 state:
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