CLASS II Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
Aripiprazole Tablets, USP, 2 mg recalled by Alembic Pharmaceuticals
Alembic Pharmaceuticals is recalling Aripiprazole Tablets, USP, 2 mg per, distributed nationwide in the US. The recall was initiated on 10 Jun 2020 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-1341-2020
- FDA event ID
- 85835
- Recalling firm
- Alembic Pharmaceuticals, Tajpura, N/A
- Brand
- Aripiprazole
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2020
- FDA classified
- 24 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 10 Jun 2020 | Recall initiated by company | |
| 24 Jun 2020 | Classified by FDA | +14 days |
| 1 Jul 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Product as listed by the FDA
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Which lots are affected?
Lot: 1905003298 Exp. 01/31/2021
Where was it sold?
Nationwide in the U.S.
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 26 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 Alembic Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride | Alembic Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib | Alembic Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
Other Aripiprazole recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole | Ajanta Pharma USA | Packaging Defects | Nationwide |
| 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 | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory Otsuka Pharmaceutical | Packaging Defects | Nationwide |
| Drug | CLASS III | Abilify (aripiprazole) recalled by Second Tokushima FactoryAbilify | Second Tokushima Factory Otsuka Pharmaceutical | Packaging Defects | Nationwide |