FDAClass IINovember 17, 2021

Tadalafil Tablets recall

Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical…

Why was Tadalafil Tablets recalled?

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
36,786 30-count bottles
Distribution
Distributed to one distributor who may have further distribute the product nationwide.
Recall date
November 17, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls