Chlorthalidone Tablets USP 25 mg — Class II drug recall D-0578-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-02-23, distributed nationwide. Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and sil
| Recall number | D-0578-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-02-07 |
| Classified | 2022-02-23 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2023-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 59,232 bottles |
| Reason classes | foreign material |
| NDC | 57664-0648, 57664-0648-18, 57664-0648-88, 57664-0649, 57664-0649-18, 57664-0649-88 |
| Lot numbers | P0602 |
| Expiration dates | 2023-03 |
Product
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.
Reason for recall
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0578-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.