Levocetirizine Dihydrochloride Tablets — Class III drug recall D-0115-2021
Terminated recall by InvaTech Pharma Solutions, LLC, reported 2020-12-09, distributed nationwide. Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count
| Recall number | D-0115-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaTech Pharma Solutions, LLC, East Brunswick, NJ, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-12-03 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2023-06-20 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 10135-0639-30 |
| Lot numbers | 051944A |
Product
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Reason for recall
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
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-0115-2021. 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.