Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Jun 5, 2026 (4 months ago)

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, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10

Affected NDCs 64980-0599-01 64980-0599-10

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.

ProductStrengthForm & routeLabelerType
Chlorthalidone
NDC 64980-0599
25 mg/1 Tablet
Oral
Rising Pharma Holdings, Inc. Rx
Recalling firm
Inventia Healthcare Limited
Origin
India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0610-2026 · 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 USP 25 mg

Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

Terminated Particulate / foreign matter Sun Pharmaceutical Industries INC NDC 57664-648-88 D-0578-2022
Class II · Moderate risk

CHLORTHALIDONE Tablets

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0172-2024

Other recalls by Inventia Healthcare Limited

All 2026 recalls