Acetaminophen 500mg Rapid Release Gelcaps Recalled for Carton Label Mix-up
Walgreen Co. is recalling Acetaminophen 500mg Rapid Release Gelcaps (Lot #31670346AA, expires 12/31/2026) due to incorrect carton labeling. The 21,192 affected bottles were distributed to retailers in Illinois.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a minor carton labeling error. No illnesses or injuries are reported, and FDA Class III recalls with labeling errors warrant a score of 2 per the rubric.
Plain-English summary
Walgreen Co. is recalling Acetaminophen USP 500mg Pain Reliever/Fever Reducer Extra Strength Rapid Release Gelcaps in 225-count HDPE bottles, manufactured by Granules Consumer Health Inc. The recalled lot number is 31670346AA with an expiration date of 12/31/2026. The recall affects 21,192 bottles of this product.
The recall was initiated because the carton packaging was incorrectly labeled. The FDA has classified this as a Class III recall. No illnesses or injuries have been reported related to this product.
The affected lot was distributed to one distributor in Illinois who may have further distributed the product to retail locations.
The recalled product
- Product
- Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
- Manufacturer
- Granules Consumer Health Inc.
- Hazard
- Affected units
- 21,192
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 #: 31670346AA
- Exp 12/31/2026
Distribution
Distributed in 1 state:
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