The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0114-2021·Announced 2020-12-09

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.

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, 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 →

Same hazard · dissolution failure

See all →

Similar recalls