The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0357-2018·Announced 2018-02-21

Toothette Oral Rinse Recalled for Cross-Contamination Risk

Sage Products Inc. is recalling Toothette Oral Care Antiseptic Oral Rinse because it was manufactured on equipment shared with non-pharmaceutical products.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Sage Products Inc. is voluntarily recalling 4,061 cases of Toothette Oral Care Antiseptic Oral Rinse, 1.5 fl.oz/44 ml. The recall is due to cross-contamination with other products, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

The affected product is distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 020387, 041657, 010507, 050926, 081026, 090636, 100176, 110575, 10786, and 120936.

Consumers should stop using the product and contact Sage Products Inc. for further instructions or a refund. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
4,061

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)

  • Product Code: 6122
  • Lots: 020387
  • EXP 02/13/2019
  • 041657
  • EXP 05/03/2019
  • 010507
  • EXP 01/16/2019
  • 050926
  • EXP 05/24/2018
  • 081026
  • EXP 08/24/2018
  • 090636
  • EXP 09/26/2018
  • 100176
  • 10/11/2018
  • 110575
  • EXP 11/24/2017
  • 10786
  • EXP 11/23/2018
  • 120936

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 64 recalled by Sage Products Inc 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 64 products in this recall →

Related recalls

Same manufacturer · Sage Products Inc

See all →

Same hazard · cross contamination

See all →

Similar recalls