Nighttime Sleep-Aid tablets recalled due to carton labeling error
CVS Pharmacy is recalling Nighttime Sleep-Aid tablets because the carton incorrectly identifies the active ingredient as doxylamine succinate HCl instead of doxylamine succinate. Approximately 257,064 cartons were distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class III recalls are typically score 1-2 per the rubric. This is a labeling error on the product carton incorrectly identifying the chemical form of the active ingredient, classified as a minor labeling error corresponding to score 2 (Moderate).
Plain-English summary
CVS Pharmacy is recalling Nighttime Sleep-Aid (doxylamine succinate) tablets, 25 mg, in 48-count blisters, due to a labeling error on the product carton. The carton incorrectly identifies the active ingredient as doxylamine succinate HCl when the product actually contains doxylamine succinate.
The recalled product was distributed nationwide through a single retailer that may have further distributed it to other locations. Approximately 257,064 cartons were affected. The products were manufactured by LNK International, Inc., with 16 affected lot codes with expiration dates from August 2023 through April 2025.
Consumers who have purchased affected lots should check the lot code and expiration date information against the FDA's recall list. Those with questions may contact their pharmacist or healthcare provider.
The recalled product
- 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.
- Manufacturer
- LNK International, Inc.
- Hazard
- Affected units
- 257,064
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 (20)
- P121512
- exp. date 08/2023
- P122015
- exp. date 09/2023
- P122712
- exp. date 11/2023
- P123090
- exp. date 12/2023
- P123170
- P124325
- exp. date 03/2024
- P124664
- P125165
- exp. date 05/2024
- P125576
- exp. date 06/2024
- P125577
- P127089
- exp. date 10/2024
- P127090
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · LNK International, Inc.
See all →- ModerateOTC Cold and Flu Medication Recalled Due to Manufacturing Process Deviations
FDA (Drugs) · 2024-12-18
- ModerateOTC Sinus Pressure and Pain Cough Product Mislabeled as Decongestant-Free
FDA (Drugs) · 2022-10-26
- LowAcetaminophen Extra Strength tablets recalled for incorrect enteric-coated labeling
FDA (Drugs) · 2021-07-28
- SevereLNK International Recalls Equate Nighttime Sleep Aid Due to Microbial Contamination
FDA (Drugs) · 2019-08-07
- ModerateWalgreens Aspirin Free Tension Headache Caplets Recalled for Undeclared Sucralose
FDA (Drugs) · 2014-12-31
Same hazard · mis labeling
See all →- ModerateEl Ruisenor De Mexico Recalls Almond Flour for Undeclared Allergen
FDA (Food) · 2026-10-28
- HighTrader Joe's Crispy Rice Milk Chocolate Bar Recalled for Undeclared Wheat
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Black Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Wheat Bran for Undeclared Wheat Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- HighAllergy Relief Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2023-07-19
- ModerateCVS Health Natural Sleep Aid Chewable Tablets Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-09
- ModerateMucinex Sinus-Max Day Night Recalled for Labeling Errors
FDA (Drugs) · 2016-09-28
- ModerateVicks NyQuil Liquid Recalled for Incorrect Undeclared Excipients Labeling
FDA (Drugs) · 2013-09-25
- SevereLNK International Recalls Equate Nighttime Sleep Aid Due to Microbial Contamination
FDA (Drugs) · 2019-08-07
- ModerateAmerican Health Packaging Recalls Doxycycline Hyclate Tablets for Dissolution Failure
FDA (Drugs) · 2019-08-07