The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1442-2020·Announced 2020-08-05

MasterPharm Recalls Vardenafil Troches Due to Lack of Processing Controls

MasterPharm LLC is recalling Vardenafil 20 mg Troches nationwide due to a lack of processing controls that ensures 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 due to a lack of processing controls. Per the rubric, this falls under 'voluntary precautionary recalls' or minor quality issues where no specific injury or illness is reported, aligning with a Moderate severity score.

Plain-English summary

MasterPharm LLC is voluntarily recalling Vardenafil 20 mg Troches, 30 troches per bottle, from the U.S. market. The recall is being conducted because of a lack of processing controls, which means there is a lack of assurance that the product conforms to specifications.

The affected product is distributed nationwide in the United States. The recall involves specific lots with the following codes and best-use-by dates: 01-21-2020:42@8 (BUD 7/19/2020), 01-24-2020:59@1 (BUD 7/22/2020), and 02-04-2020:65@11 (BUD 8/2/2020). The total quantity involved is 134 troches.

Consumers who have purchased this product should stop using it and contact MasterPharm LLC at (866) 630-5600 for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Manufacturer
MasterPharm LLC
Category
Drug — Prescription Medication
Hazard
Affected units
134

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)

  • 01-21-2020:42@8
  • BUD 7/19/2020 01-24-2020:59@1
  • BUD 7/22/2020 02-04-2020:65@11
  • BUD 8/2/2020

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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