The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0231-2022·Announced 2021-11-17

Tadalafil Tablets Recalled Due to Incorrect Product Formulation

Sun Pharmaceutical is recalling Tadalafil Tablets USP 20 mg due to use of an incorrect grade of Crospovidone during manufacturing. The recall affects 36,786 bottles distributed to one distributor.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 an FDA Class II recall involving a manufacturing defect (incorrect grade of excipient). No hospitalizations, illnesses, or injuries are reported in the source text, and the hazard is a formulation issue rather than contamination or high-risk pathogen. The classification meets the threshold for Moderate severity.

Plain-English summary

Sun Pharmaceutical Industries Inc is recalling Tadalafil Tablets, USP 20 mg, 30-count bottles because an incorrect grade of Crospovidone was used during manufacturing. The affected product was manufactured for Northstar Rx LLC in Memphis, Tennessee.

The recall involves 36,786 bottles of product with Lot Numbers DNC0814A and DNC0815A, with an expiration date of 04/2023. The product was distributed to one distributor who may have further distributed the product nationwide.

Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. The product is identified by NDC # 16714-077-01.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug — Prescription / Erectile Dysfunction
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 (3)

  • Lot # DNC0814A
  • DNC0815A
  • Exp. Date 04/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES 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 2 products in this recall →

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