Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0852-2021·Announced 2021-10-06

Drug recall: Daytime/Nighttime Severe Cold & Flu Relief vials subpotent

New Vision Pharmaceuticals is recalling Daytime and Nighttime Severe Cold & Flu Relief single-use vials because the drug is subpotent—meaning it contains less active ingredient than intended. The recall was initiated voluntarily on September 2, 2021.

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: This is a FDA Class III recall with no reported illnesses or injuries stated in the source text. The hazard (subpotent drug) is a manufacturing/formulation defect rather than a contamination or acute safety risk, and the source explicitly indicates this is a precautionary recall initiated voluntarily by the firm. Class III recalls typically score 1 or 2; in this case, because a pharmaceutical product's reduced efficacy is a meaningful quality concern, a score of 2 (Moderate) applies.

Plain-English summary

New Vision Pharmaceuticals LLC is recalling Daytime Severe Cold & Flu Relief (8 Pre-Measured Vials, 0.51 FL OZ each, Mixed Berry flavor, NDC 69842-495-16) and Nighttime Severe Cold & Flu Relief (8 Pre-Measured Vials, 1.01 FL OZ each, Mixed Berry flavor, NDC 69842-495-16) distributed by CVS Pharmacy, Inc. The recalled product consists of 14,976 cartons with Lot 2021-10159, expiring 06/08/2023.

The recall was issued because the drug product is subpotent, meaning it does not contain the full amount of active ingredient as formulated. This is a voluntary, firm-initiated recall classified by the FDA as Class III.

The affected product was distributed to the following states: Alabama, California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, and Virginia.

Consumers who have purchased this product should stop using it and dispose of it properly. Retailers and healthcare providers should remove the product from shelves and return it to the distributor. For questions, consumers may contact the recalling firm or their healthcare provider.

The recalled product

Product: 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…
Manufacturer: New Vision Pharmaceuticals LLC
Category: Drug — Over-the-Counter Cold & Flu Relief
Hazard: subpotent-drug
reduced-efficacy
Affected units: 14,976

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 (1)

Lot: 2021-10159 Exp. 06/08/2023

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 →

Same manufacturer · New Vision Pharmaceuticals LLC

See all →

Low
CVS Health Daytime Cold & Flu Relief Drug Recalled for Subpotency
FDA (Drugs) · 2021-10-06

Same hazard · subpotent drug