The Recall Desk
ModerateFDA (Drugs)·D-1423-2020·Announced 2020-08-05

MasterPharm Recalls Formula 82F Minoxidil Tretinoin Fluocinolone Acetonide Finasteride

MasterPharm LLC is recalling 462 units of Formula 82F topical solution due to a lack of processing controls that compromised product specifications.

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 and involves a lack of processing controls without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

MasterPharm LLC is voluntarily recalling 462 units of Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottles. The recall was initiated because of a lack of processing controls, which means there was a lack of assurance that the product conformed to its specifications.

The affected product was distributed nationwide in the U.S. The specific lots involved include those with manufacturing dates of 01-15-2020, 01-09-2020, 01-20-2020, 01-23-2020, 01-29-2020, and 02-03-2020, with corresponding best-use dates ranging from July 2020 to late July 2020.

Consumers who have this product should stop using it and contact MasterPharm LLC at (866) 630-5600 for instructions on how to return the product or obtain a refund.

The recalled product

Product
Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15 mL) bottle MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600.
Manufacturer
MasterPharm LLC
Affected units
462

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 (7)

  • 01-15-2020:70@3
  • 01-09-2020:48@2
  • BUD 7/7/2020 01-20-2020:79@11
  • 01-23-2020:55@11
  • BUD 7/18/2020 01-29-2020:18@1
  • 02-03-2020:89@8
  • BUD 7/26/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 recalled by MasterPharm 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 26 products in this recall →