Aripiprazole Tablets USP Recall Due to Product Mix-Up
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Ajanta Pharma USA Inc. is recalling 6,143 bottles of Aripiprazole Tablets USP 30 mg after a bottle of Voriconazole Tablets 50 mg was mislabeled as Aripiprazole.
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
Ajanta Pharma USA Inc. initiated a voluntary recall of Aripiprazole Tablets USP after a product mix-up. A bottle containing Voriconazole Tablets 50 mg was labeled and distributed as Aripiprazole Tablets USP 30 mg.
Which Products Are Affected
- Product: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets
- Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807
- Made in India
- NDC: 27241-056-03
- Lot: PA00805, expires 01/31/2029
- Quantity: 6,143 bottles
- Distribution: U.S. Nationwide
- Recall number: D-0594-2026
What You Should Do
Consumers should check the lot number on any Aripiprazole Tablets USP 30 mg bottles in their possession. The recalling firm initiated the recall via letter.
Why This Matters
The mislabeling introduces a risk of patients receiving the incorrect medication, as the recalled product is a human prescription drug classified as Class II by the FDA.
Source
FDA recall D-0594-2026, Ajanta Pharma USA Inc.
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 (984 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.