The Recall Desk
LowFDA (Drugs)·D-0853-2021·Announced 2021-10-06

CVS Health Daytime Cold & Flu Relief Drug Recalled for Subpotency

CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials are being recalled because the product is subpotent—containing less active ingredient than intended. The recall affects specific lot numbers distributed across 14 U.S. states.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall for a subpotent drug with no reported illnesses or injuries. The hazard is product efficacy rather than safety, and no harm has been reported. Per the severity rubric, Class III recalls are typically scored 1 or 2, and absent any reported adverse effects, a score of 1 is appropriate.

Plain-English summary

CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials in Mixed Berry Flavor are being recalled due to subpotency. The affected product is the 8 Pre-Measured Vials package (0.51 FL OZ each, 4.06 FL OZ total) with NDC 69842-499-08 and UPC 0 50428 64130 9, manufactured by New Vision Pharmaceuticals LLC and distributed by CVS Pharmacy, Inc.

The recall affects approximately 18,864 cartons distributed across Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, and Virginia. The affected lot numbers are 2021-10154 (Expiration 06/29/2023) and 2021-10164 (Expiration 06/11/2023).

This is a voluntary recall initiated by the manufacturer on September 2, 2021, and classified by the FDA as Class III. Consumers who have purchased this product should stop using it and may return it to the place of purchase. The recall was terminated on June 21, 2023.

The recalled product

Product
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
Manufacturer
New Vision Pharmaceuticals LLC
Category
Drug — Over-the-Counter Cold & Flu Relief
Hazard
Affected units
18,864

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 (2)

  • Lots: 2021-10154 Exp. 06/29/2023
  • 2021-10164 Exp. 06/11/2023

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 2 recalled by New Vision Pharmaceuticals LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · New Vision Pharmaceuticals LLC

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Same hazard · subpotent drug

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