The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0230-2017·Announced 2016-12-28

Sage Products Recalls Comfort Shield Barrier Cream Cloths Due to CGMP Deviations

Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths due to CGMP deviations and potential contamination on shared equipment.

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 indicates a temporary or medically reversible adverse health consequence. The source cites CGMP deviations and potential contamination without reporting specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Sage Products LLC is voluntarily recalling multiple lots of Comfort Shield Barrier (dimethicone) Cream Cloths. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations that created a risk of potential contamination in products manufactured on the same equipment and lines as the contaminated product.

The affected product is a topical over-the-counter skin barrier cream cloth containing 3% dimethicone. The recall covers 616,561 cases distributed nationwide, in Puerto Rico, and in several international locations including Canada, the United Kingdom, Germany, and Australia. Specific lot numbers and expiration dates are listed in the structured product information.

Consumers and healthcare providers should check their inventory for the affected lot numbers and stop using the product if it matches the recall details. Those with questions or concerns should contact Sage Products LLC or the FDA for further instructions.

The recalled product

Product
COMFORT SHIELD BARRIER (DIMETHICONE)
Brand
COMFORT SHIELD BARRIER
Manufacturer
Sage Products LLC
Category
Drug — OTC Skin Barrier
Hazard
Affected units
616,561

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)

  • Lot #: a) 45489
  • Exp. 8/23/2016
  • 45537
  • Exp. 8/25/2016
  • 45631
  • Exp. 9/1/2016
  • 45781
  • Exp. 9/10/2016
  • 46345
  • Exp. 10/18/2016
  • 46708
  • Exp. 11/9/2016
  • 46763
  • Exp. 11/11/2016
  • 47378
  • Exp. 1/5/2017
  • 47723
  • Exp. 1/27/2017
  • 48347
  • Exp. 3/4/2017

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 3 recalled by Sage Products 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 3 products in this recall →

Related recalls

Same brand · COMFORT SHIELD BARRIER

Same manufacturer · Sage Products LLC

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Same hazard · contamination

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