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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 99046

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 27, 2026
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ajanta Pharma USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0594-2026
Recall number
D-0594-2026
Initiated
May 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Ajanta Pharma USA Inc
Quantity
6,143 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

Code information

Lot: PA00805, expires: 01/31/2029

Distribution pattern

U.S. Nationwide