CLASS II Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
Chlorthalidone Tablets USP 25 mg recalled
SUN Pharmaceutical Industries is recalling Chlorthalidone Tablets USP 25 mg, distributed nationwide in the US. The recall was initiated on 7 Feb 2022 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-0578-2022
- FDA event ID
- 89529
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Chlorthalidone
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2022
- FDA classified
- 23 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Blood Pressure Medication
Timeline
| 7 Feb 2022 | Recall initiated by company | |
| 23 Feb 2022 | Classified by FDA | +16 days |
| 23 Feb 2022 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Product as listed by the FDA
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.
Where it was distributed
Nationwide with the United States
Questions about this recall
Why was it recalled?
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Which lots are affected?
Lot #: P0602, Exp. Date 03/2023
Where was it sold?
Nationwide with the United States
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.
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 Chlorthalidone recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25 mg recalled by Inventia HealthcareChlorthalidone | Inventia Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr recalledChlorthalidone | Inventia Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25 mg Unit Dose cards recalled by AvKAREChlorthalidone | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Chlorthalidone Tablets, USP, 25MG recalled by Cardinal HealthcareChlorthalidone | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Chlorthalidone, Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |