Ajanta Pharma Fluphenazine Hydrochloride Tablets Recall Over Impurity Specifications
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Ajanta Pharma USA Inc. is recalling Fluphenazine Hydrochloride Tablets, USP 1mg due to failed organic impurities specifications.
The full picture behind this FDA recall
This notice was issued by FDA on September 22, 2026 and geographically references United States. The FDA classifies this as a Class III recall, with the stated reason "Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.", distributed nationwide within the u.s. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. 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.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Ajanta Pharma USA Inc. initiated a voluntary recall after Fluphenazine Hydrochloride Tablets failed impurities/degradation specifications. Testing at the 18 months long term stability showed Organic Impurities by HPLC (Impurity-A) at 1.1 percent, exceeding the 1.0 percent specification.
Which Products Are Affected
The recall covers Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles (NDC 27241-255-01), marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, made in India. Affected lots are DJ23254 (Exp. Date 11/30/2026) and DJ10205 (Exp. Date 04/30/2027). A total of 403,200 tablets are involved in the nationwide U.S. distribution. This is FDA recall number D-0836-2026, classified as Class III.
What You Should Do
Consumers with questions should contact the recalling firm regarding the affected product.
Why This Matters
The recall addresses a quality specification failure in a prescription drug distributed nationwide.
Source
FDA Enforcement Report, recall number D-0836-2026, event ID 99733.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,051 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to September 22, 2026.
Questions & Answers
Common questions about this FDA recall.