Harvard Drug Group Recalls Aripiprazole Tablets for Dissolution Failure
The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.
What this means for you
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, which typically involves a situation that may cause temporary or medically reversible health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute injury risk.
Plain-English summary
The Harvard Drug Group is voluntarily recalling 841 cartons of Aripiprazole Tablets, USP, 15 mg. The product is distributed by Major Pharmaceuticals and manufactured by Apotex, Inc. The recall is limited to specific lots: T02520 and T02637, with an expiration date of 02/2021.
The recall was initiated because the tablets failed to meet required dissolution specifications. Dissolution is a critical quality attribute that ensures the medication breaks down properly in the body to be absorbed. When this specification is not met, the medication may not work as intended.
The recalled product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected medication.
The recalled product
- Product
- Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 841
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)
- Lots: T02520
- T02637
- exp 02/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · The Harvard Drug Group
See all →- ModerateTramadol Hydrochloride Tablets Recalled Due to Inadequate Blister Packaging Seal
FDA (Drugs) · 2023-07-05
- ModerateGabapentin tablets recalled due to product mixup with foreign tablet
FDA (Drugs) · 2023-05-17
- HighCarbidopa and Levodopa Tablets Recalled for Inadequate Blister Packaging Seal
FDA (Drugs) · 2023-03-08
- ModeratehydrALAZINE HCl Tablets 10 mg Recalled for Failed Impurity Specifications
FDA (Drugs) · 2022-03-23
- ModeratePaliperidone Extended-Release Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-03-16
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
- ModerateChlorthalidone 25mg tablets failed dissolution specifications in two batches
FDA (Drugs) · 2026-06-24
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17