The Recall Desk
ModerateFDA (Drugs)·D-0070-2022·Announced 2021-11-03

PainAway II Acetaminophen/Aspirin/Caffeine Tablets Recalled for Failed Stability

Ultra Seal Corporation is recalling PainAway II tablets nationwide due to failed stability specifications. Testing found out-of-specification levels of Salicylic Acid, an aspirin-related compound.

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 involving a labeling/quality issue (failed stability specifications) with no reported illnesses or injuries. The hazard is based on out-of-specification test results rather than confirmed harm or a high-risk pathogen, placing it in the Moderate category per the rubric.

Plain-English summary

Ultra Seal Corporation is recalling PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets distributed nationwide in the USA. The recall affects 2,484,274 tablets packaged in 2 tablets per packet within 12,000 packets per case (Material # 11161), manufactured for Respond Industries First Aid in Mason, Ohio.

The recall was initiated because stability testing revealed out-of-specification results for Salicylic Acid, an aspirin-related compound. This indicates the product did not meet required stability specifications.

Affected lot numbers include: AK-9336 (expiration 21-Oct); K9406 and AK-9407 (expiration 21-Dec); K-9860 (expiration 22-Oct); and AK-1057 (expiration 23-Feb). Consumers who have purchased this product should stop use and consult their healthcare provider if they have questions or concerns.

The recalled product

Product
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Pain Reliever
Hazard
  • failed-stability-specifications
  • out-of-specification-aspirin-related-compound

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 (9)

  • Lot #: AK-9336
  • exp. date 21-Oct
  • K9406
  • AK-9407
  • exp. date 21-Dec
  • K-9860
  • exp. date 22-Oct
  • AK-1057
  • exp. date 23-Feb

Distribution

Distributed nationwide across the United States.

Related recalls

Same category