Skin Protectant with Lanolin Recalled for Manufacturing Facility Contamination
Skin Protectant with Lanolin, manufactured by DermaRite Industries, is being recalled due to CGMP violations and contamination detected in other products at the same manufacturing facility. Nationwide distribution; 5,876 units affected.
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: This is an FDA Class II precautionary recall with no contamination confirmed in this specific product and no reported illnesses or injuries. The recall is based on a CGMP deviation at the manufacturing facility where other products have been contaminated, consistent with the rubric category of voluntary precautionary recalls.
Plain-English summary
DermaRite Industries, LLC, is recalling Skin Protectant with Lanolin due to manufacturing facility contamination. The product is distributed by McKesson Medical-Surgical Inc. and is available in two package sizes: 5g tubes (NDC 68599-6202-1) and 4oz tubes (NDC 68599-6203-4).
The recall was initiated because the manufacturing facility has not followed Current Good Manufacturing Practice (CGMP) standards. Contamination has been identified in other products and lots manufactured at this same facility, raising concerns about the safety of all products produced there during the affected period.
The recalled product has been distributed nationwide throughout the United States. Approximately 5,876 units are affected, including all lots expiring on or before August 2027.
Consumers who have purchased this product should discontinue use immediately. If you have used this product and have concerns about potential contamination exposure, contact your healthcare provider or pharmacist for guidance.
The recalled product
- Product
- SKIN PROTECTANT WITH LANOLIN (LANOLIN)
- Brand
- SKIN PROTECTANT WITH LANOLIN
- Manufacturer
- DermaRite Industries, LLC
- Category
- Drug — Topical OTC / Skin Care
- Hazard
- manufacturing-deviation
- contamination-risk
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)
- All lots on or before expiry date 08/2027
UPCs (2)
- 0612479216839
- 0612479216877
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27