CareOne Allergy Relief Tablets (Ohm Laboratories) – Superpotent Drug (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Ohm Laboratories, Inc.
Lot Codes / Batch Numbers
Batch Numbers: (a) 2617891, Exp 5/31/2016, 2600127, Exp 2/29/2016, 2544487, Exp 7/31/2015, 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016, 2544487, Exp 7/31/2015, 2617891, Exp 5/31/2016, 2644272, Exp 9/30/2016
Products Sold
Batch Numbers: (a) 2617891, Exp 5/31/2016; 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2610783, Exp 4/30/2016 (b) 2600127, Exp 2/29/2016; 2544487, Exp 7/31/2015; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Ohm Laboratories, Inc. is recalling CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, US due to Superpotent Drug: Out Of Specification (OOS) result for Assay.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026