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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

CVS Nighttime Sleep-Aid Recalled for Incorrect Drug Ingredient Labeling

Agency Publication Date: August 30, 2022
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Summary

LNK International, Inc. has voluntarily recalled approximately 257,064 cartons of CVS Health Nighttime Sleep-Aid (doxylamine succinate) tablets. The recall was initiated because the outer carton incorrectly identifies the product as doxylamine succinate HCl, though the tablets actually contain doxylamine succinate. This error involves 48-count blister packs that were distributed to CVS Pharmacy locations across the United States. No incidents or injuries have been reported to date.

Risk

While the product contains the intended active medication, the chemical form listed on the package is technically incorrect. This labeling error may cause confusion for consumers or healthcare professionals regarding the specific chemical composition of the drug.

What You Should Do

  1. This recall involves CVS Health Nighttime Sleep-Aid (doxylamine succinate) tablets, 25 mg, sold in 48-count blister cartons with UPC 0 50428 34873 4.
  2. Identify if your product is affected by checking the lot number and expiration date printed on the carton. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact LNK International, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Nighttime Sleep-Aid (doxylamine succinate) (48-count)by CVS Health
Variants: 25 mg, Tablets, Blister pack
UPC Codes:
050428348734
Lot Numbers:
P121512 (Exp 08/2023)
P122015 (Exp 09/2023)
P122712 (Exp 11/2023)
P123090 (Exp 12/2023)
P123170 (Exp 12/2023)
P124325 (Exp 03/2024)
P124664 (Exp 03/2024)
P125165 (Exp 05/2024)
P125576 (Exp 06/2024)
P125577 (Exp 06/2024)
P127089 (Exp 10/2024)
P127090 (Exp 10/2024)
P127386 (Exp 11/2024)
P128572 (Exp 01/2025)
P128383 (Exp 01/2025)
P129536 (Exp 04/2025)

Recall #: D-1472-2022. Firm initiated recall via letter notification.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90708
Status: Resolved
Manufacturer: LNK International, Inc.
Sold By: CVS Pharmacy, Inc.; CVS Pharmacy
Manufactured In: United States
Units Affected: 257,064 cartons
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.