The Recall Desk
ModerateFDA (Drugs)·D-0076-2022·Announced 2021-11-03

Xpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications

Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.

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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is related to failed stability testing, which represents a precautionary action rather than confirmed harm. Per the rubric, FDA Class III recalls typically score 1 or 2, and since no actual harm has been reported, a Moderate (2) score is appropriate.

Plain-English summary

Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets distributed nationwide in the USA. The recall affects approximately 42,394,018 tablets packaged as 2 tablets per package in cases of 12,000 packets, with Material# 111519, manufactured for Cintas First Aid & Safety, Mason, OH 45040.

The recall is due to failed stability specifications. Out-of-specification results were observed for Salicylic Acid, a compound related to Aspirin. This indicates the product did not meet required stability testing standards.

Multiple lot numbers are affected with various expiration dates ranging from October 2021 through July 2023, including lots: K-9335, AK-9419, AK-9369, AK-9403, AK-9452, K-9455, AK-9586, AK-9525, AK-9526, AK-9639, AK-9568, AK-9569, AK-9567, AK-9692, AK-9615, AK-9666, AK-9714, K-9714, AK-9718, K-9718, AK-9719, AK-9771, AK-9765, AK-9769, AK-9822, AK-9818, AK-9860, AK-9957, AK-1011, K-1014, AK-9489, 1055, K-1057, AK-1058, AK-1108, AK-1113, K-1199, AK-1199, AK-1240, AK-1278, and K-1240.

Consumers who have purchased this product should stop using it and contact Ultra Seal Corporation or their healthcare provider for further guidance.

The recalled product

Product
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Pain Reliever
Hazard
  • failed-stability-testing
  • out-of-specification-salicylic-acid

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 (20)

  • Lot #: K-9335
  • AK-9419
  • exp. date 21-Oct
  • AK-9369
  • exp. date 21- Nov
  • AK-9403
  • exp. date 21-Dec
  • AK-9452
  • K-9455
  • 9455
  • exp. date 22-Jan
  • AK-9586
  • exp. date 22-Feb
  • AK-9525
  • AK-9526
  • AK-9639
  • exp. date 22-Mar
  • AK-9568
  • AK-9569
  • AK-9567

Distribution

Distributed nationwide across the United States.

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