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
Affected units
2,484,274

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.

Part of a larger recall action

This product is one of 8 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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