RecallRadar

FDA Drug recall D-0029-2016

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204,…

On 2015-10-21 the FDA classified a Class III recall of HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204,… by Ohm Laboratories, citing superpotent Drug: Out Of Specification (OOS) result for Assay.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0029-2016
ClassificationClass III
Statusterminated
Initiated2015-07-28
Published2015-10-21
Last updated2026-09-13 11:51 UTC
CompanyOhm Laboratories
DistributionUS

Product

HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3

Reason

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

Identifiers

upc041220819683
code_infoBatch Numbers: 2544486, Exp 7/31/2016; 2600127, Exp 2/29/2016; 2617891, Exp 5/31/2016; 2644265, Exp 9/30/2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0029-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.