Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm I...

FDA Drug Recall #D-0578-2022 — Class II — February 7, 2022

Recall Summary

Recall Number D-0578-2022
Classification Class II — Moderate risk
Date Initiated February 7, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SUN PHARMACEUTICAL INDUSTRIES INC
Location Princeton, NJ
Product Type Drugs
Quantity 59,232 bottles

Product Description

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

Distribution Pattern

Nationwide with the United States

Lot / Code Information

Lot #: P0602, Exp. Date 03/2023

Other Recalls from SUN PHARMACEUTICAL INDUSTRIES INC

Recall # Classification Product Date
D-0342-2026 Class II Diclofenac Sodium, Topical Gel, 3%, 100 g tube,... Jan 27, 2026
D-0256-2026 Class III Fluocinolone Acetonide Solution Topical Solutio... Dec 30, 2025
D-0257-2026 Class III Clindamycin Phosphate USP, 1% (10 mg/mL), Topic... Nov 26, 2025
D-0149-2026 Class II Lisdexamfetamine Dimesylate Capsules, 60 mg, CI... Oct 28, 2025
D-0150-2026 Class II Lisdexamfetamine Dimesylate Capsules, 70 mg, CI... Oct 28, 2025

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.