CLASS II Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Aripiprazole Tablets, USP, 10 mg recalled
Hetero Labs Ltd. - Unit III is recalling Aripiprazole Tablets, USP, 10 mg, distributed in New Jersey. The recall was initiated on 10 Jan 2018 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-0594-2018
- FDA event ID
- 78809
- Recalling firm
- Hetero Labs Ltd. - Unit III, Hyderabad, N/A
- Brand
- Aripiprazole
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2018
- FDA classified
- 13 Mar 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 10 Jan 2018 | Recall initiated by company | |
| 14 Feb 2018 | Published in enforcement report | +35 days |
| 13 Mar 2018 | Classified by FDA | +27 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Product as listed by the FDA
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Where it was distributed
NJ Only
Questions about this recall
Why was it recalled?
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Which lots are affected?
Lot #: ARI17089, ARI17090, Exp. 5/2019
Where was it sold?
NJ Only
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 Hetero Labs Ltd. - Unit III
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit IIIFenofibrate | Hetero Labs Ltd. - Unit III | Other | IN, LA |
| Drug | CLASS II | Indomethacin Capsules, USP, 50 mg recalledIndomethacin | Hetero Labs Ltd. - Unit III | Other | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 40 mg recalled by Hetero Labs, Ltd. - Unit IIISimvastatin | Hetero Labs Ltd. - Unit III | Other | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution, USP, 100 mg/mL recalledLevetiracetam | Hetero Labs Ltd. - Unit III | Packaging Defects | NJ |
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 |