The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1424-2020·Announced 2020-08-05

MasterPharm Recalls Formula 82M Due to Lack of Processing Controls

MasterPharm LLC is recalling 543 units of Formula 82M topical solution nationwide because the product lacks assurance of conformity to specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The specific reason is a lack of processing controls, which is a quality assurance issue rather than a confirmed contamination or defect causing immediate harm.

Plain-English summary

MasterPharm LLC is recalling 543 units of Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%) in 0.5 FL OZ (15 mL) and 2 FL OZ (60 mL) bottles. The recall was initiated due to a lack of processing controls, which means there is a lack of assurance that the product conforms to its specifications.

The affected product was distributed nationwide in the United States. The recall covers specific production dates and expiration dates, including batches manufactured between January 13, 2020, and February 21, 2020, with expiration dates ranging from July 7, 2020, to August 16, 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 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Manufacturer
MasterPharm LLC
Category
Drug — Topical Solution
Hazard
Affected units
543

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 (9)

  • 01-17-2020:45@4
  • 01-13-2020:40@27
  • BUD 7/7/2020 01-21-2020:43@11
  • BUD 7/18/2020 01-28-2020:88@15
  • 01-31-2020:73@6
  • BUD 7/26/2020 02-12-2020:43@16
  • 02-17-2020:86@5
  • BUD 8/10/2020 02-21-2020:23@1
  • BUD 8/16/2020

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 →

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