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Unrated Drug recall · FDA · Published December 15, 2015

Morton Grove Recalls Lindane Lotion Due to Assay Issues

Morton Grove Pharmaceuticals recalls specific lots of Lindane Lotion USP 1% due to out-of-specification assay results. Check your bottle's lot number and expiration date.

🇺🇸 FDA recall #D-0571-2016DrugMorton Grove Pharmaceuticals ›
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Recalling firmMorton Grove Pharmaceuticals, Inc.6451 Main St · Morton Grove, IL 60053-2633
✎ GovInfoNow plain-language explainer

What happened, in plain English

Morton Grove Pharmaceuticals, Inc. is recalling Lindane Lotion, USP 1%, because stability samples showed out-of-specification assay test results. The recall affects 39,187 bottles distributed nationwide and in Puerto Rico. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/43335-morton-grove-recalls-lindane-lotion-due-to-assay-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/43335-morton-grove-recalls-lindane-lotion-due-to-assay-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0571-2016

Cite this page

“Morton Grove Recalls Lindane Lotion Due to Assay Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43335-morton-grove-recalls-lindane-lotion-due-to-assay-issues. Based on FDA recall #D-0571-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0571-2016%22&limit=1).

Why it’s dangerous

The hazard is that the drug's active ingredient concentration may be outside the specified limits due to failed stability testing. The record does not specify if this results in under-dosing or over-dosing, nor does it describe specific health risks associated with the deviation.

Who’s affected

Consumers who purchased Lindane Lotion from retailers across the United States and Puerto Rico between the production date and December 15, 2015. Individuals using this prescription medication for external use are the primary group affected.

How to tell if you have this one

Look for a 2 fl oz (60 mL) bottle labeled 'Lindane Lotion, USP 1%, For External use Only, Rx Only' with NDC 60432-833-60. Check the lot numbers UP1103 (Expiration 04/2016) and UQ1001 (Expiration 04/2017).

  • Brand
    Morton Grove Pharmaceuticals
  • Category
    Drug

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

1. Firm started the recall: Dec 15, 201512. FDA classified it Class III: Jan 15, 201623. Published in FDA’s Enforcement Report: Jan 27, 201634. FDA terminated the recall: Sep 13, 2016420152016
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0571-2016 (December 15, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0571-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA