The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1512-2020·Announced 2020-08-26

Ultra Seal Recalls Pain Relief Tablets Due to Stability Failures

Ultra Seal Corporation is recalling specific lots of Pain Relief Maximum Strength tablets because they failed stability specifications for salicylic acid.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure without reported injuries or illnesses.

Plain-English summary

Ultra Seal Corporation is voluntarily recalling 4,666,355 packets of Pain Relief Maximum Strength tablets. The product contains acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg per two-tablet packet and was manufactured for Select Corporation in Carrollton, Texas.

The recall was initiated because the product failed stability specifications. Specifically, out-of-specification (OOS) results were observed for salicylic acid, an aspirin-related compound. The affected lots are AK8745 (Exp. 08/20), AK9751 (Exp. 08/2021), and AK9552 (Exp. 04/2022).

The product was shipped to two distributors in Illinois and Texas, who may have further repackaged and distributed the items. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Analgesic
Hazard
Affected units
4,666,355

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 (6)

  • Lot #: AK8745
  • Exp. Date 08/20
  • AK9751
  • Exp. Date 08/2021
  • AK9552
  • Exp. Date 04/2022

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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