The Recall Desk
ModerateFDA (Drugs)·D-0075-2022·Announced 2021-11-03

Advance Formula Pain Reliever tablets recalled for failed stability specifications

Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for 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 out-of-specification stability test results for an impurity (Salicylic Acid). Class III recalls are typically scored 1 or 2. The source text does not report any illnesses, injuries, or deaths, and the hazard is a manufacturing/quality issue rather than an active safety threat. A score of 2 reflects precautionary monitoring of a quality defect.

Plain-English summary

Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets containing Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg, packaged as 2 tablets per packet. The recall affects 991,310 tablets manufactured for Advanced First Aid (Baltimore, MD) and American Safety & First Aid (Osceola, IN).

The recall was initiated due to failed stability specifications. Out-of-specification results were observed for Salicylic Acid, an Aspirin-related compound. The affected lots are: AK-9457 (expiration 22-Jan), AK-9521 (expiration 22-Mar), AK-9959 (expiration 22-Dec), and AK-1017 (expiration 23-Jan).

The product was distributed nationwide in the USA. Consumers who have purchased this product should stop using it and contact the manufacturer or healthcare provider with questions.

The recalled product

Product
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shippin
Manufacturer
Ultra Seal Corporation
Category
Drug — Pain Reliever / Combination Analgesic
Hazard
  • stability-test-failure
  • out-of-specification-impurity

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 (8)

  • Lot #: AK-9457
  • exp. date 22-Jan
  • AK-9521
  • exp. date 22-Mar
  • AK-9959
  • exp. date 22-Dec
  • AK-1017
  • exp. date 23-Jan

Distribution

Distributed nationwide across the United States.

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