The Recall Desk
ModerateFDA (Drugs)·D-0470-2022·Announced 2022-02-09

Legatrin PM Pain Reliever/Sleep Aid Recalled for cGMP Deviations

Ultra Seal Corporation is recalling 174,852 bottles of Legatrin PM Pain Reliever/Sleep Aid nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated on January 24, 2022.

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: The recall is FDA Class II and voluntary with no reported illnesses or injuries mentioned in the source. The hazard is a manufacturing practice deviation rather than a direct safety threat to consumers, supporting a Moderate severity rating.

Plain-English summary

Ultra Seal Corporation is recalling Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50 mg caplets) in 50-count bottles nationwide due to current Good Manufacturing Practice (cGMP) deviations. The affected product was manufactured for Church & Dwight Co., Inc., Ewing, NJ 08628 with NDC 10237-907-50.

The recall includes 174,852 bottles distributed nationwide within the United States. The affected lot numbers and expiration dates are: Lot #HY9042 (Exp. Date 02/2022), Lot #HY9094 and HY9112 (Exp. Date 04/2022), Lot #HY9134 (Exp. Date 05/2022), and Lot #HY9267 (Exp. Date 09/2022).

This is a voluntary recall initiated by the firm on January 24, 2022, and classified as FDA Class II. Consumers who have purchased affected bottles should discontinue use. The recall was terminated on October 16, 2023.

The recalled product

Product
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
Manufacturer
Ultra Seal Corporation
Category
Drug — Pain Reliever / Sleep Aid
Hazard
Affected units
174,852

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 (9)

  • Lot #: HY9042
  • Exp. Date 02/2022
  • HY9094
  • HY9112
  • Exp. Date 04/2022
  • HY9134
  • Exp. Date 05/2022
  • HY9267
  • 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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