Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated May 27, 2026 (5 months ago)

Aripiprazole Tablets USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

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.

Affected NDC 27241-0056-03

Compare with the code on your package — it is the most precise check available.

Drug: Aripiprazole

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Aripiprazole
NDC 27241-0056
30 mg/1 Tablet
Oral
Ajanta Pharma USA Inc. Rx
Recalling firm
Ajanta Pharma USA Inc
NDC code
27241-056-03
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0594-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Aripiprazole recalls

See all
Class III · Low risk

Abilify (aripiprazole)

Cross Contamination with Other Products

Ongoing Cross-contamination Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. NDC 59148-011-13 D-0469-2024
Class III · Low risk

Abilify (aripiprazole)

Cross Contamination with Other Products

Ongoing Cross-contamination Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. NDC 59148-009-13 D-0468-2024
Class III · Low risk

Abilify (aripiprazole)

Cross Contamination with Other Products

Ongoing Cross-contamination Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. NDC 59148-008-13 D-0467-2024
Class III · Low risk

Abilify (aripiprazole)

Cross Contamination with Other Products

Ongoing Cross-contamination Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. NDC 59148-007-13 D-0466-2024

Other recalls by Ajanta Pharma USA Inc

All 2026 recalls
Class III · Low risk

Fluphenazine Hydrochloride Tablets

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.

Ongoing Impurity / degradation Ajanta Pharma USA Inc NDC 27241-255-01 D-0836-2026
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Ongoing Nitrosamine impurity Ajanta Pharma Ltd. NDC 27241-097-06 D-0516-2026
Class II · Moderate risk

Duloxetine Delayed-Release Capsules

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

Ongoing Nitrosamine impurity Ajanta Pharma Ltd. NDC 27241-099-03 D-0515-2026