Ultra Seal Corporation recalls MidNite Sleep Health melatonin tablets due to cGMP deviations. Affected lots expire 02/2022 to 07/2022. Consumers should check labels for lot numbers and expiration dates.
cGMP deviations
Ultra Seal Corporation is recalling MidNite Sleep Health melatonin tablets (1.5 mg) because of manufacturing quality control issues. This recall affects specific batches that may have been produced under improper conditions, though the exact risk to consumers is not specified in the notice.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the tablets were produced under conditions that do not meet standard quality control requirements. This could potentially affect the safety and effectiveness of the product, but the exact risk to consumers is not clearly described in the recall notice.
People who purchased MidNite Sleep Health melatonin tablets from Mylan Consumer Healthcare, Inc. in the U.S. are affected. Those with the specific lot numbers and expiration dates listed are most at risk.
Check the product label for lot numbers: 18L124-18L126 (expiring 02/2022), 19C037-19C040 (expiring 03/2022), 19D029-19D031 (expiring 04/2022 and 06/2022), or 19G047 (expiring 07/2022). The product is distributed by Mylan Consumer Healthcare, Inc. in the U.S.
Look for lot numbers on the label: 18L124-18L126 (expiring 02/2022), 19C037-19C040 (expiring 03/2022), 19D029-19D031 (expiring 04/2022 and 06/2022), or 19G047 (expiring 07/2022).
The recall is due to cGMP deviations, which means the tablets were produced under conditions that do not meet standard quality control requirements.
Check the product label for the lot numbers listed. If you have the affected lot numbers, contact Ultra Seal Corporation for instructions.
The recall notice does not specify the exact safety risks, only that there were manufacturing quality control 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-0475-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0475-2022 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.
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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.