New Vision Pharmaceuticals LLC is recalling CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials because the medication may be subpotent, meaning it might not work as intended. The recall affects specific lots distributed in several states. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/35867-cvs-health-cold-flu-vial-recall-subpotent-drug-risk.
“CVS Health Cold & Flu Vial Recall: Subpotent Drug Risk.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35867-cvs-health-cold-flu-vial-recall-subpotent-drug-risk. Based on FDA recall #D-0853-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0853-2021%22&limit=1).
The FDA announced on September 2, 2021, that New Vision Pharmaceuticals LLC voluntarily recalled CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials due to subpotent drug risks. The recall affects 18,864 FG cartons distributed in several states.
How to tell if you have it
Brand: CVS Health
Product: Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL)
The product is classified as a subpotent drug, meaning it may not contain the active ingredient levels required for effective treatment. The FDA assigned this recall a Class III classification.
Context
GovInfoNow's records show other recent recalls of similar products include CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (2026-03-18), Bell Pharmaceuticals Carbamide Peroxide 6.5% Recall (2026-06-25), and Specialty Process Labs Thyroid Product Recall (2026-01-16).
How to tell if you have this one
Check if you have CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials, Mixed Berry Flavor, 8 Pre-Measured Vials (0.51 FL OZ each). Look for NDC 69842-499-08 and UPC 0 50428 64130 9. Affected lots are 2021-10154 (Exp. 06/29/2023) and 2021-10164 (Exp. 06/11/2023).
Brand
CVS Health
Product
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL)
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA
Recall number
Product, codes & lots
Quantity
D-0852-2021
Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; Lot: 2021-10159 Exp. 06/08/2023
14,976 FG cartons
D-0853-2021
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895; Lots: 2021-10154 Exp. 06/29/2023; 2021-10164 Exp. 06/11/2023
18,864 FG cartons
Based on the official FDA remedy
What to do — step by step
Check Your Product
Verify if your vials match the NDC, UPC, and lot numbers listed in the recall record.
Monitor for Updates
Since no remedy is stated in the current record, check official sources for future instructions on returns or disposal.
Where it went and when
Where it was distributed
Distributed in 14 states.
Listed by the agency
Not listed
FDA distribution: “AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0853-2021 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0853-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.