The Recall Desk
ModerateFDA (Drugs)·D-0553-2023·Announced 2023-05-03

Tadalafil Tablets 20 mg recalled due to manufacturing deviations

Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. 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: This is a voluntary, precautionary FDA Class II recall with no reported illnesses or injuries. The specific manufacturing deviations are not detailed in the source, leaving the actual product hazard theoretical rather than established.

Plain-English summary

Northwind Pharmaceuticals LLC is voluntarily recalling Tadalafil Tablets, USP 20 mg distributed nationwide in the United States. The recall affects two package sizes: 6-count bottles (NDC 51655-473-87) and 15-count bottles (NDC 51655-473-54). Specific lot numbers and expiration dates are available in FDA recall notice D-0553-2023.

The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards. No illnesses or injuries have been reported. This is a voluntary FDA Class II recall initiated by the manufacturer on March 16, 2023.

Patients currently taking Tadalafil should verify the lot and expiration date of their medication against those listed in the recall notice. Those with affected batches should consult their healthcare provider before taking any action. Healthcare providers and pharmacists should be alert to patients inquiring about this recall.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug — Prescription
Hazard

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 (8)

  • a) Lot #: F113892002
  • Exp. Date 08/31/2023
  • F113892201
  • Exp. Date 11/30/2023 b) Lot #: F113892001
  • F113892202
  • Exp. Date 11/30/2023
  • F113892203
  • Exp. Date 12/31/2023

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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