Recalls / Class II
Class IID-0461-2025
Product
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
- Brand name
- Chlorthalidone
- Generic name
- Chlorthalidone
- Active ingredient
- Chlorthalidone
- Route
- Oral
- NDC
- 50268-167
- FDA application
- ANDA210742
- Affected lot / code info
- Lot # 47947, Exp 05/31/2026
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- AvKARE
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 962 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2025-05-09
- FDA classified
- 2025-06-09
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0461-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.