Morton Grove Recalls Lindane Lotion Due to Out-of-Specification Assay
Morton Grove Pharmaceuticals is recalling specific lots of Lindane Lotion because stability samples failed assay testing. Consumers should stop using the product and return it to their pharmacy.
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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a quality control failure (assay) rather than a direct safety hazard like contamination or mislabeling of a common allergen.
Plain-English summary
Morton Grove Pharmaceuticals, Inc. is recalling 39,187 bottles of Lindane Lotion, USP 1%, 2 fl oz (60 mL). The recall affects products with NDC 60432-833-60, specifically Lot UP1103 (Exp 04/2016) and Lot UQ1001 (Exp 04/2017). The product was distributed nationwide and in Puerto Rico.
The recall was initiated because out-of-specification assay test results were reported for stability samples. This indicates that the concentration of the active ingredient in the recalled lots may not meet the required standards.
Consumers who have this product should stop using it and return it to their pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
- Manufacturer
- Morton Grove Pharmaceuticals, Inc.
- Affected units
- 39,187
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 (4)
- Lot #: UP1103
- Exp 04/2016
- UQ1001
- Exp 04/2017
Distribution
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