Use cautionDrug recall · FDA · Published February 7, 2022
Sun Pharma Chlorthalidone Tablets Recall: Foreign Metal Particles Hazard
Sun Pharma recalls 25mg Chlorthalidone tablets with stainless steel particles. Foreign matter in tablets may cause injury. Stop using and contact for return.
“Sun Pharma Chlorthalidone Tablets Recall: Foreign Metal Particles Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35233-sun-pharma-chlorthalidone-tablets-recall-foreign-metal-particles-hazard. Based on FDA recall #D-0578-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0578-2022%22&limit=1).
SUN PHARMACEUTICAL INDUSTRIES INC recalled Chlorthalidone Tablets USP 25 mg nationwide due to potential contamination with foreign matter, the FDA said in a Feb. 7, 2022 announcement. The Class II recall involved 59,232 bottles distributed across the United States.
Manufacturer: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadelphia, PA 19124
Distributor: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC: 57664-648-88
Lot #: P0602
Expiration Date: 03/2023
Quantity: 59,232 bottles
The hazard
The recall was initiated because foreign matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup was found in the product. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show SUN PHARMACEUTICAL INDUSTRIES INC has 93 other recalls on record since 2013-05-21. Recent brand recalls include Tretinoin Cream (2026-09-25), Carbamazepine Tablets (2026-08-03), and Perampanel 6mg Tablets (2026-06-17). Other recent recalls of similar products include Guardian Drug Family Wellness Antacid Tablets (2026-05-28), Goodsense Ultra Strength Antacid Tablets (2026-05-28), and TopCare Antacid Tablets (2026-05-28).
How to tell if you have this one
Check for the product name 'Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets' from Sun Pharma. The lot number is P0602 with an expiration date of 03/2023.
Brand
Sun Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled Chlorthalidone tablets if you have them.
Contact Sun Pharma
Reach out to Sun Pharma for a replacement or refund.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide with the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0578-2022 (February 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0578-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.