Nighttime Sleep-Aid (LNK International) – Incorrect Labeling (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Brand
LNK International, Inc.
Lot Codes / Batch Numbers
P121512, exp. date 08/2023, P122015, exp. date 09/2023, P122712, exp. date 11/2023, P123090, exp. date 12/2023, P123170, exp. date 12/2023, P124325, exp. date 03/2024, P124664, exp. date 03/2024, P125165, exp. date 05/2024, P125576, exp. date 06/2024, P125577, exp. date 06/2024, P127089, exp. date 10/2024, P127090, exp. date 10/2024, P127386, exp. date 11/2024, P128572, exp. date 01/2025, P128383, exp. date 01/2025, P129536, exp. date 04/2025
Products Sold
P121512, exp. date 08/2023; P122015, exp. date 09/2023; P122712, exp. date 11/2023; P123090, exp. date 12/2023; P123170, exp. date 12/2023; P124325, exp. date 03/2024; P124664, exp. date 03/2024; P125165, exp. date 05/2024; P125576, exp. date 06/2024; P125577, exp. date 06/2024; P127089, exp. date 10/2024; P127090, exp. date 10/2024; P127386, exp. date 11/2024; P128572, exp. date 01/2025; P128383, exp. date 01/2025; P129536, exp. date 04/2025
LNK International, Inc. is recalling Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distrib due to Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026