CLASS II ONGOING Drug recall · Reported 24 Jun 2026 · FDA Enforcement Report
Aripiprazole Tablets recalled by Ajanta Pharma USA
Ajanta Pharma USA is recalling Aripiprazole Tablets USP, distributed nationwide in the US. The recall was initiated on 27 May 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0594-2026
- FDA event ID
- 99046
- Recalling firm
- Ajanta Pharma USA, Bridgewater, NJ
- Brand
- Aripiprazole
- Manufacturer
- Ajanta Pharma USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 May 2026
- FDA classified
- 16 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 27 May 2026 | Recall initiated by company | |
| 16 Jun 2026 | Classified by FDA | +20 days |
| 24 Jun 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Aripiprazole Tablets USP recalled?
Yes. Ajanta Pharma USA recalled Aripiprazole Tablets USP on 27 May 2026. The recall is Class II and its status is Ongoing. Recall number D-0594-2026.
Why was it recalled?
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Which lots are affected?
Lot: PA00805, expires: 01/31/2029
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ajanta Pharma USA
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluphenazine Hydrochloride Tablets, USP, 1mg recalledFluphenazine Hydrochloride | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate | Ajanta Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
Other Aripiprazole recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aripiprazole Tablets, USP, 10 mg recalled by Ascend LaboratoriesAripiprazole | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory, Otsuka Pharmaceutical Co | Packaging Defects | Nationwide |