Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Jul 28, 2015 (11 years ago)

CareOne Original Prescription Strength

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

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

Affected NDCs 41520-0525-69 41520-0527-69

Compare with the code on your package — it is the most precise check available.

Drug: Loratadine Category: Allergy & Cold Medication

Recalling firm
Ohm Laboratories, Inc.
NDC code
41520-525-69
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0022-2016 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Loratadine recalls

See all

Other recalls by Ohm Laboratories, Inc.

All 2015 recalls