Class II · Moderate risk Ongoing
Tadalafil USP
Reason CGMP Deviations:Noted during FDA inspection
Tadalafil Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
What was recalled
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 16714-077-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0231-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tadalafil recalls
See all
Class II · Moderate risk Ongoing
Tadalafil USP
Reason CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk Ongoing
Tadalafil USP
Reason CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk Ongoing
Tadalafil Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Terminated
Tadalafil 5 mg tablets
Reason cGMP Deviations
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