Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

CareOne Original Prescription Strength Recalled by Ohm Laboratories, Inc. Due to Superpotent Drug: Out Of Specification (OOS) result for...

Date: July 28, 2015
Company: Ohm Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ohm Laboratories, Inc. directly.

Affected Products

CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086

Quantity: 21,356 boxes

Why Was This Recalled?

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ohm Laboratories, Inc.

Ohm Laboratories, Inc. has 23 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report