The Recall Desk
ModerateFDA (Drugs)·D-1440-2020·Announced 2020-08-05

MasterPharm Recalls Tadalafil 7 mg Capsules Due to Processing Control Deficiencies

MasterPharm LLC is recalling Tadalafil 7 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 recall is classified as FDA Class II due to a lack of processing controls, which is a quality assurance issue rather than a direct contamination or mislabeling of a common allergen. No illnesses or injuries are reported in the source text, and the hazard is theoretical regarding conformity to specifications, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

MasterPharm LLC is voluntarily recalling Tadalafil 7 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 its specifications.

The affected product is manufactured by MasterPharm LLC, located at 115-02 Liberty Ave, Richmond Hill, NY 11419. The recall covers approximately 12,000 capsules across four specific production lots with expiration dates ranging from July 2020 to August 2020. The specific lot codes and expiration dates are: 01-08-2020:45@16 (BUD 7/6/2020), 01-22-2020:02@19 (BUD 7/20/2020), 02-13-2020:05@3 (BUD 8/11/2020), and 02-24-2020:95@12 (BUD 8/22/2020).

Consumers who have purchased these specific lots of Tadalafil 7 mg capsules should stop using the product 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, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Tadalafil 7 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
12,000

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 (5)

  • 01-08-2020:45@16
  • BUD 7/6/2020 01-22-2020:02@19
  • BUD 7/20/2020 02-13-2020:05@3
  • BUD 8/11/2020 02-24-2020:95@12
  • BUD 8/22/2020

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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