Ultra Seal Corporation recalls Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500mg, diphenhydramine 50mcg) 50-count bottles due to cGMP deviations. Affected lots have specific expiration dates and NDC numbers.
cGMP deviations
Ultra Seal Corporation is recalling Legatrin PM Pain Reliever/Sleep Aid caplets because of manufacturing quality issues. This recall affects specific batches with known expiration dates and NDC numbers. The product contains acetaminophen and diphenhydramine.
The recall is due to cGMP deviations, which are manufacturing quality issues that could affect product safety. However, the specific risks are not detailed in the recall notice.
People who own or use Legatrin PM Pain Reliever/Sleep Aid caplets from the specified lots and expiration dates are affected. Those who have the product with the listed NDC numbers and lot codes are most at risk.
Check for the product name 'Legatrin PM Pain Reliever/Sleep Aid' with 50-count bottles. Look for the NDC number 10237-907-50 and specific lot numbers (HY9042, HY9094, HY9112, HY9134, HY9267) with their expiration dates.
Identify the NDC number 10237-907-50 and lot numbers (HY9042, HY9094, HY9112, HY9134, HY9267) with their expiration dates.
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles.
Lot numbers: HY9042 (exp. 02/2022), HY9094 (exp. 04/2022), HY9112 (exp. 04/2022), HY9134 (exp. 05/2022), HY9267 (exp. 09/2022).
Due to cGMP deviations, which are manufacturing quality issues.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0470-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0470-2022 from Ultra Seal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
