The Recall Desk
HighFDA (Drugs)·D-0554-2023·Announced 2023-05-03

Tadalafil Tablets Recalled Due to Manufacturing Practice Violations

Northwind Pharmaceuticals is recalling 23 bottles of Tadalafil 5 mg tablets nationwide due to manufacturing process deviations. The FDA classified this as a Class II recall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification indicates potential for adverse health consequences. CGMP deviations represent manufacturing process failures that could affect product quality and safety. While no illnesses or injuries have been reported, the product poses a risk of harm, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Northwind Pharmaceuticals LLC has issued a voluntary recall of Tadalafil Tablets, USP 5 mg, in 30-count bottles. The recall affects 23 bottles distributed nationwide with lot number F114302001 and an expiration date of May 31, 2023.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. CGMP violations indicate that the product was not manufactured according to FDA standards for quality and safety.

Patients who received this medication should consult with their healthcare provider or pharmacist to determine if they have been affected by this recall. The medication should not be used if it bears the recalled lot number and expiration date.

Consumers with questions or concerns about this recall should contact their pharmacy or healthcare provider. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug — Prescription / Erectile Dysfunction
Hazard
Affected units
23

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 #: F114302001
  • Exp. Date 05/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Northwind Pharmaceuticals 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 7 products in this recall →

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