CLASS II Drug recall · Reported 17 Nov 2021 · FDA Enforcement Report
Tadalafil Tablets, USP 5 mg recalled by Sun Pharmaceutical Industries
SUN Pharmaceutical Industries is recalling Tadalafil Tablets, USP 5 mg, distributed nationwide in the US. The recall was initiated on 25 Oct 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0230-2022
- FDA event ID
- 88873
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Tadalafil
- Manufacturer
- NorthStar RxLLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2021
- FDA classified
- 12 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 25 Oct 2021 | Recall initiated by company | |
| 12 Nov 2021 | Classified by FDA | +18 days |
| 17 Nov 2021 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Where it was distributed
Distributed to one distributor who may have further distribute the product nationwide.
Questions about this recall
Why was it recalled?
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Which lots are affected?
Lot # DNC1127A, exp. date 05/2023
Where was it sold?
Distributed to one distributor who may have further distribute the product nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88873| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tadalafil Tablets, USP 20 mg recalled by Sun Pharmaceutical IndustriesTadalafil | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Tadalafil recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tadalafil Tablets, USP 5 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil Tablets, USP 20 mg recalled by Northwind PharmaceuticalsTadalafil | Northwind Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged recalled | RemedyRepack | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil Tablets, USP, 20 mg recalled by Preferred PharmaceuticalsTadalafil | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tadalafil Tablets, USP, 5 mg recalled by Accord HealthcareTadalafil | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |