Chlorthalidone Tablets Recall Issued for Failed Dissolution
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Rising Pharma Holdings, Inc. is recalling 11,460 bottles of Chlorthalidone Tablets, USP 25 mg due to failed dissolution specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Inventia Healthcare Limited initiated a voluntary recall of Chlorthalidone Tablets, USP, 25 mg after the products failed dissolution specifications. The recall is classified as Class II by the FDA and affects products distributed nationwide in the United States.
Which Products Are Affected
The recall covers Chlorthalidone Tablets, USP, 25 mg in 100-tablet bottles (NDC 64980-599-01) and 1000-tablet bottles (NDC 64980-599-10). Affected batches are RISA24001 (100-tablet) and RISB24002 (1000-tablet), both with expiration date 04/2027. A total of 11,460 bottles are involved. The tablets were manufactured by Inventia Healthcare Limited in Ambernath, India, and distributed by Rising Pharma Holdings, Inc.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding the recalled product. No specific return or refund instructions are provided in the recall notice.
Why This Matters
Failed dissolution specifications may affect the drug's intended release and therapeutic effect.
Source
FDA recall number D-0610-2026; data from FDA enforcement report.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,118 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.