CVS Health Natural Sleep Aid Chewable Tablets Recalled for Manufacturing Deviations
CVS Health Natural Sleep Aid Chewable Tablets (melatonin 1.5mg) in cherry flavor are being recalled nationwide due to cGMP manufacturing deviations. The manufacturer, Ultra Seal Corporation, initiated the voluntary recall of 241,560 bottles.
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: This is an FDA Class II recall involving cGMP deviations, a manufacturing process violation. The source text does not report any illnesses, injuries, or deaths. The recall is precautionary in nature, making it a moderate-severity recall per the rubric criteria for manufacturing process violations without reported harm.
Plain-English summary
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), distributed in 30-count bottles, are subject to a voluntary recall by the manufacturer, Ultra Seal Corporation, in collaboration with CVS Pharmacy Inc.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. The affected product was distributed nationwide within the United States. The recall involves 241,560 bottles with lot numbers 18L124 (expiration date 02/2022) and 19D029 (expiration date 04/2022).
Consumers who have purchased this product should stop using it. The FDA classified this as a Class II recall. The recall was voluntarily initiated by the firm and the U.S. Food and Drug Administration confirmed the manufacturer's notification on January 31, 2022.
The recalled product
- Product
- CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Sleep Aid / Melatonin
- Hazard
- cGMP-deviation
- manufacturing-defect
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 (4)
- Lot #: 18L124
- Exp. Date 02/2022
- 19D029
- Exp. Date 04/2022
Distribution
Distributed nationwide across the United States.
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