The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0482-2022·Announced 2022-02-09

Backache & Muscle Relief Drug Recalled for cGMP Deviations

Ultra Seal Corporation is recalling Backache & Muscle Relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5.1 million packets distributed across the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 II, which typically warrants a score of 2–4. However, the source explicitly identifies the hazard as cGMP deviations (a manufacturing-process deviation) with no reported illnesses, injuries, or product-quality failures described. This is a precautionary manufacturing-compliance recall without reported harm, placing it at the lower end of the Class II range.

Plain-English summary

Ultra Seal Corporation is voluntarily recalling Backache & Muscle Relief, a pain-relief medication containing acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290 mg, and caffeine 50 mg per 2-tablet packet. The product is manufactured for First Aid Direct, Mason, OH. The recall was initiated on January 24, 2022, due to cGMP deviations identified during manufacturing.

Approximately 5,107,565 packets were distributed nationwide within the United States. Affected lots and expiration dates include: Lot K9770 and AK9770 (Exp. 08/2022); AK9958 and K9958 (Exp. 12/2022); AK9717 (Exp. 07/2022); AK9522 and AK9641 (Exp. 03/2022); and AK9817 (Exp. 09/2022). The product is identified by NDC 42961-111-832.

Consumers who have purchased this product should stop using it and consult their healthcare provider if they have taken it. The recall was classified as FDA Class II and was terminated on October 16, 2023.

The recalled product

Product
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
Manufacturer
Ultra Seal Corporation
Category
Drug — Pain Relief / OTC Combination
Hazard
Affected units
5,107,565

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 (11)

  • Lot #: K9770
  • AK9770 Exp. Date 08/2022
  • AK9958
  • K9958 Exp. Date 12/2022
  • AK9717
  • Exp. Date 07/2022
  • AK9522
  • AK9641
  • Exp. Date 03/2022
  • AK9817
  • Exp. Date 09/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 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 56 products in this recall →

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