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.
What this means for you
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
- 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
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
- CriticalSage Products Recalls Comfort Shield Barrier Cream Cloths Due to Bacteria
FDA (Drugs) · 2016-12-28
- HighSage Recalls Comfort Shield Barrier Cream Cloths Due to Bacterial Contamination
FDA (Drugs) · 2014-09-10
Same manufacturer · Sage Products LLC
See all →- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to CGMP Deviations
FDA (Drugs) · 2016-12-28
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02