The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0073-2022·Announced 2021-11-03

AERO Tab Pain Reliever Tablets Recalled for Failed Stability Specifications

Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 stability/specification failure rather than a confirmed safety hazard with reported illness or injury. The source text does not indicate any actual illnesses, injuries, or deaths, making this a precautionary recall of the type typically classified as Moderate.

Plain-English summary

Ultra Seal Corporation is recalling AERO Tab PAIN RELIEVER tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide in the USA. The recall affects approximately 1,480,981 tablets in multiple lots with various expiration dates.

The recall was initiated due to failed stability specifications. Out-of-specification results were observed for Salicylic Acid, an Aspirin-related compound, indicating that the product did not meet required stability standards during testing.

Consumers who have purchased this product should stop using it. Those with questions or who may have been affected should contact their healthcare provider or the recalling firm, Ultra Seal Corporation.

The recalled product

Product
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
Manufacturer
Ultra Seal Corporation
Category
Drug — Pain Reliever / Over-the-Counter
Hazard
Affected units
1,480,981

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 (10)

  • Lot #: K-1278
  • exp. date 23-Jul
  • K-9371
  • AK-9463
  • exp. date 21-Nov
  • AK-9821
  • AK-9819
  • exp. date 22-Sep
  • 1107
  • exp. date 23-Mar.

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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