The Recall Desk
LowFDA (Drugs)·D-0072-2022·Announced 2021-11-03

ZEE+ Painaid ESF Tablets Recalled for Failed Stability Specifications

Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).

What this means for you

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 failed stability specifications with no reported illnesses or injuries. The hazard is theoretical and relates to quality control rather than an immediate safety threat. Class III recalls are typically scored as 1 or 2 per the rubric.

Plain-English summary

Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide. The tablets contain Acetaminophen 250 mg, Aspirin 250 mg (NSAID), and Caffeine 65 mg, and are sold in 2-tablet packages within 50-count and 125-count cartons (lot number PA-ESF 1414Z).

The recall has been initiated due to failed stability specifications. Out-of-specification results were observed for Salicylic Acid, an aspirin-related compound. A total of 1,968,150 tablets are affected by this recall.

Affected lot numbers are AK-9547 (expiration date April 22) and AK-9941 (expiration date December 22). These products were distributed nationwide in the USA and are distributed by Zee Medical Distributors, LLC in Mason, Ohio.

Consumers who have purchased these products should discontinue use and consult their healthcare provider with questions about their health or the use of this product.

The recalled product

Product
ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shi
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-counter pain relief
Hazard
  • stability-failure
  • out-of-specification

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 (4)

  • Lot #: AK-9547
  • exp. date 22- Apr
  • AK-9941
  • exp. date 22-Dec

Distribution

Distributed nationwide across the United States.

Related recalls

Same category