The Recall Desk
ModerateFDA (Drugs)·D-1436-2020·Announced 2020-08-05

MasterPharm Recalls Tadalafil 12 mg Capsules Due to Processing Control Deficiencies

MasterPharm LLC is recalling Tadalafil 12 mg capsules nationwide due to a lack of processing controls that ensures conformity to 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 FDA classified this recall as Class II, which typically corresponds to a moderate severity where the probability of serious adverse health consequences is remote or the consequences are temporary. No specific injuries or illnesses were reported in the source text.

Plain-English summary

MasterPharm LLC is voluntarily recalling Tadalafil 12 mg capsules, 90 capsules per bottle, distributed nationwide in the United States. The recall is being conducted due to a lack of processing controls, which means there is a lack of assurance that the product conforms to specifications.

The affected product is identified by the following codes: 01-23-2020:62@14 with a best-use date of 7/21/2020, and 02-26-2020:56@14 with a best-use date of 8/24/2020. The total quantity involved in the recall is 600 capsules.

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 U.S. Food and Drug Administration (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, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Manufacturer
MasterPharm LLC
Category
Drug — Prescription Medication
Hazard
Affected units
600

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 (3)

  • 01-23-2020:62@14
  • BUD 7/21/2020 02-26-2020:56@14
  • BUD 8/24/2020

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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