Lindane Lotion (Morton Grove Pharmaceuticals) – Out of Specification (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
Brand
Morton Grove Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #: UP1103, Exp 04/2016, UQ1001, Exp 04/2017
Products Sold
Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017
Morton Grove Pharmaceuticals, Inc. is recalling Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-6 due to Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026