Chlorthalidone Tablets recall
FDA recall D-0461-2025 · initiated May 9, 2025
AvKARE recalled Chlorthalidone Tablets in May 2025 — an FDA Class II recall (D-0461-2025) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 962 cartons
Details
- 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
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA
- Initiated
- May 9, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Chlorthalidone Tablets recalled?
- AvKARE recalled Chlorthalidone Tablets in May 2025 — an FDA Class II recall (D-0461-2025) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Chlorthalidone Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0461-2025 was: Failed Dissolution Specifications
- Is a recalled Chlorthalidone Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Chlorthalidone Tablets are affected?
- Distributed: Nationwide USA. The recall covers these lots — Lot # 47947, Exp 05/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0461-2025.