Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Chlorthalidone Tablets USP 25 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
57664-0648-88
Compare with the code on your package — it is the most precise check available.
Drug: Chlorthalidone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Chlorthalidone NDC 57664-0648 |
25 mg/1 | Tablet Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 57664-648-88
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0578-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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