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.
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 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
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.
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