The Recall Desk
ModerateFDA (Drugs)·D-0497-2023·Announced 2023-04-12

Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations

RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.

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: FDA Class II voluntary recall initiated by the manufacturer with no reported illnesses or injuries. The hazard is manufacturing process deviations (cGMP) without specified contamination or defect details, fitting the 'voluntary precautionary recalls' criterion.

Plain-English summary

RemedyRepack Inc. recalled Tadalafil 5 mg tablets in 30-count bottles due to manufacturing practice deviations. The recalled product carries lot number B1635780-040522 with an expiration date of April 30, 2023. A total of 16 bottles were affected by this recall.

The recall was initiated because the manufacturer did not follow FDA-required manufacturing practices (cGMP standards). These standards ensure drugs are made consistently and meet quality requirements. While no illnesses or injuries have been reported, the manufacturing deviations posed a potential quality and safety risk.

The product was distributed by RemedyRepack Inc. to consignees nationwide throughout the United States. This is a prescription medication that may be held by healthcare providers, pharmacies, or individual patients.

Patients taking this product should speak with their healthcare provider or pharmacist for guidance. Do not stop taking a prescription medication without first consulting your doctor or pharmacist.

The recalled product

Product
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard
Affected units
16

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 (2)

  • Lot #: B1635780-040522
  • Exp. Date 04/30/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by RemedyRepack Inc. 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 14 products in this recall →

Related recalls

Same manufacturer · RemedyRepack Inc.

See all →

Same hazard · manufacturing deviation

See all →