Walgreens Aspirin Free Tension Headache Caplets Recalled for Undeclared Sucralose
LNK International recalled specific lots of Walgreens Aspirin Free Tension Headache Caplets because they contain sucralose, an ingredient not listed on the label.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II and involves a minor labeling error (undeclared excipient) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
LNK International, Inc. is recalling specific lots of Walgreens brand Aspirin Free Tension Headache Caplets. The product is an over-the-counter pain reliever containing acetaminophen and caffeine. The recall was initiated because the caplets contain sucralose, an excipient that was not declared on the product label.
The recall affects 9,379 bottles distributed nationwide. The specific lots involved are P78221 and P78222, both with an expiration date of 05/14. The product is identified by NDC 0363-0428-12 and UPC Code 311917134925.
Consumers who have purchased these specific lots should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925
- Manufacturer
- LNK International, Inc.
- Category
- Drug — OTC Pain Reliever
- Hazard
- Affected units
- 9,379
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 (3)
- Lot Number P78221
- expiration date 05/14
- Lot Number P78222
Distribution
Distributed nationwide across the United States.
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