Hetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations
Hetero Labs is recalling 3,000 bottles of Aripiprazole 10 mg tablets because the active ingredient did not meet all intended specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Hetero Labs, Ltd. is recalling 3,000 bottles of Aripiprazole Tablets, USP, 10 mg. The product is a prescription-only medication manufactured for Camber Pharmaceuticals, Inc. The specific lots affected are ARI17089 and ARI17090, with an expiration date of 5/2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the lots were made with an active pharmaceutical ingredient that did not meet all its intended specifications. The distribution was limited to New Jersey.
Consumers who have these specific lots of Aripiprazole tablets should stop using them and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Hetero Labs, Ltd. - Unit III
- Category
- Drug — Prescription Medication
- Affected units
- 3,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: ARI17089
- ARI17090
- Exp. 5/2019
UPCs (2)
- 0331722828055
- 0331722820301
Distribution
Distributed in 1 state:
Related recalls
Same brand · ARIPIPRAZOLE
- HighAripiprazole 30mg bottle contained voriconazole 50mg tablets instead
FDA (Drugs) · 2026-06-24
- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModeratePrescription Aripiprazole tablets recalled nationwide for storage temperature deviation
FDA (Drugs) · 2024-01-03
- HighAntipsychotic Drug Recalled for Failed Quality Control Test
FDA (Drugs) · 2023-04-26
- HighAccord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2023-03-08
Same manufacturer · Hetero Labs, Ltd. - Unit III
See all →- ModerateFenofibrate Tablets Recalled Due to Foreign Valacyclovir Tablet Presence
FDA (Drugs) · 2018-10-03
- ModerateHetero Labs Recalls Indomethacin Capsules Due to Deformed or Clumped Units
FDA (Drugs) · 2018-08-08
- HighSimvastatin Tablets Recalled Due to Presence of Metallic Razor Blade
FDA (Drugs) · 2018-01-24
- HighLevetiracetam Oral Solution Recalled Due to Foreign Screw Presence
FDA (Drugs) · 2017-12-06
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateAripiprazole Tablets Recalled Due to CGMP Deviations and API Specification Failures
FDA (Drugs) · 2018-02-21
- ModerateDrug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-04-12
- HighAccord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2023-03-08
- HighAripiprazole 20 mg Tablets Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2023-03-08
- ModeratePrescription drug aripiprazole tablets recalled for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- ModerateAripiprazole Tablets Recalled Following FDA Inspection for Manufacturing Deviations
FDA (Drugs) · 2023-03-08