Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Chlorthalidone Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDC
50268-0167-15
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 50268-0167 |
25 mg/1 | Tablet Oral |
AvPAK | Rx |
- Recalling firm
- AvKARE
- NDC code
- 50268-167-15
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0461-2025 · 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.
Other Chlorthalidone recalls
See all
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Chlorthalidone Tablets USP 25 mg
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Class II · Moderate risk
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CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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All 2025 recalls
Class II · Moderate risk
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Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
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Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
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Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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