The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0230-2022·Announced 2021-11-17

Tadalafil Tablets Recalled for Incorrect Product Formulation

Sun Pharmaceutical Industries is recalling Tadalafil 5 mg tablets (Lot # DNC1127A) because an incorrect grade of Crospovidone was used during manufacturing. The product was distributed to one distributor who may have further distributed it nationwide.

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 formulation defect (incorrect excipient grade). No illnesses or injuries are reported in the source text, and no specific safety outcome is stated. The recall appears to be precautionary in nature, warranting a Moderate severity rating.

Plain-English summary

Sun Pharmaceutical Industries Inc is recalling Tadalafil Tablets, USP 5 mg, 30-count bottles due to incorrect product formulation. An incorrect grade of Crospovidone was used to manufacture the product. This is a Class II recall issued by the FDA.

The affected product includes Lot # DNC1127A with an expiration date of 05/2023, bearing NDC # 16714-075-01. Approximately 73,957 30-count bottles were affected. The product was distributed to one distributor who may have further distributed the product nationwide.

Consumers who have this product should consult their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should quarantine the product and return it to the manufacturer.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug — Prescription Pharmaceutical
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 (2)

  • Lot # DNC1127A
  • exp. date 05/2023

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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