Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

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

CVS Health Severe Cold & Flu Relief Vials Recalled for Being Subpotent

Agency Publication Date: September 24, 2021
Share:
Sign in to monitor this recall

Summary

New Vision Pharmaceuticals LLC is recalling 33,840 units of CVS Health Daytime and Nighttime Severe Cold & Flu Relief single-use vials because they were found to be subpotent. This means the medication may not contain the full amount of active ingredients needed to effectively treat symptoms as intended. No incidents or injuries have been reported to date. The recalled products were sold at CVS Pharmacy locations in 14 states and are packaged in cartons containing pre-measured vials in mixed berry flavor.

Risk

A subpotent drug contains less than the required amount of medicine, which means it may fail to treat cold and flu symptoms effectively. While the reported health risk is low, consumers using this product may not receive the therapeutic benefits expected from the medication.

What You Should Do

  1. This recall affects CVS Health Daytime and Nighttime Severe Cold & Flu Relief single-use vials in Mixed Berry Flavor with NDC 69842-495-16 (UPC 050428640579) and NDC 69842-499-08 (UPC 050428641309).
  2. Check your product packaging for affected lot numbers 2021-10159 (Exp 06/08/2023), 2021-10154 (Exp 06/29/2023), or 2021-10164 (Exp 06/11/2023).
  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 New Vision Pharmaceuticals LLC directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for 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: Daytime Severe Cold & Flu Relief / Nighttime Severe Cold & Flu Relief Combo Pack
Variants: Mixed Berry Flavor, Single-Use Vials, Daytime: 0.51 FL OZ, Nighttime: 1.01 FL OZ
UPC Codes:
050428640579
Lot Numbers:
2021-10159 (Exp. 06/08/2023)
NDC:
69842-495-16

Quantity: 14,976 FG cartons

Product: CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials
Variants: Mixed Berry Flavor, 0.51 FL OZ Vials
UPC Codes:
050428641309
Lot Numbers:
2021-10154 (Exp. 06/29/2023)
2021-10164 (Exp. 06/11/2023)
NDC:
69842-499-08

Quantity: 18,864 FG cartons

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88608
Status: Resolved
Manufacturer: New Vision Pharmaceuticals LLC
Sold By: CVS Pharmacy, Inc.
Manufactured In: United States
Units Affected: 2 products (14,976 FG cartons; 18,864 FG cartons)
Distributed To: Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia

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.