ZEE Aspirin Recalled for Incorrect Inactive Ingredient Labeling
ZEE Medical is recalling ZEE Aspirin 325mg tablets because the product label incorrectly lists inactive ingredients.
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, which typically involves a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a labeling error regarding inactive ingredients, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
ZEE Medical is recalling ZEE Aspirin 325mg, 24 tablets in single dose packets, over-the-counter. The recall was initiated because the product label contains an incorrect listing of inactive ingredients.
The affected product was manufactured for ZEE Medical Inc. by ULTRA Tab Laboratories, Inc. A total of 43,752 boxes were distributed nationwide in the United States. The recall covers specific lot numbers: AK5425, AK5172, AK5548, AK6047, AK6114, AK5865, AK5963, AK6175, AK6346, AK6438, and AK7062.
Consumers should check their medication for these lot numbers. If the product matches the description and lot numbers listed, they should stop using it and contact ZEE Medical or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
- Manufacturer
- Zee Medical Products Inc
- Hazard
- Affected units
- 43,752
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 (11)
- Lot No. AK5425
- AK5172
- AK5548
- AK6047
- AK6114
- AK5865
- AK5963
- AK6175
- AK6346
- AK6438
- AK7062
Distribution
Distributed nationwide across the United States.
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