The Recall Desk
ModerateFDA (Drugs)·D-0041-2015·Announced 2014-10-29

ZEE Aspirin Recalled for Incorrect Inactive Ingredient Labeling

ZEE Medical is recalling ZEE Aspirin 325mg tablets because the product label incorrectly lists inactive ingredients.

What this means for you

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
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.