Loratadine Orally Disintegrating Tablets USP — Class III drug recall D-1142-2015
Terminated recall by Ohm Laboratories, Inc., reported 2015-06-24, distributed nationwide. Superpotent Drug: Out Of Specification (OOS) result for Assay.
| Recall number | D-1142-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ohm Laboratories, Inc., North Brunswick, NJ, United States |
| Recall initiated | 2015-05-04 |
| Classified | 2015-06-18 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 2,592 blister |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00050428113677, 00311917155623 |
| Lot numbers | 2625094 |
| Expiration dates | 2016-06 |
Product
Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)
Reason for recall
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1142-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.