The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0074-2022·Announced 2021-11-03

North by Honeywell Pain Stopper Extra Strength tablets recalled for failed stability

Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets nationwide because stability testing found out-of-specification results for Salicylic Acid, an aspirin-related compound.

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: The FDA classified this as Class III, which typically corresponds to a score of 1 or 2. The source text does not report any illnesses, injuries, or deaths. The hazard is a failed stability specification—a quality/manufacturing issue rather than an acute safety threat—making this a moderate precautionary recall.

Plain-English summary

Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets (containing Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg) distributed nationwide in the United States. The recall was initiated because stability testing identified out-of-specification results for Salicylic Acid, a compound related to aspirin.

The affected product is Lot #AK-9371 with an expiration date of November 21. The product was packaged in cases of 5,000 packets (2 tablets per packet), for a total of 250,000 tablets, and distributed by Honeywell Safety Products USA in Smithfield, Rhode Island.

Consumers who have purchased this product should stop using it and consult their healthcare provider if they have questions or concerns about their health.

The recalled product

Product
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-counter analgesic
Hazard
Affected units
250,000

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 (2)

  • Lot #: AK-9371
  • exp. date 21-Nov

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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