Lorazepam Tablets — Class II drug recall D-0085-2018
Terminated recall by Leading Pharma, LLC, reported 2017-11-29, distributed nationwide. Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepa
| Recall number | D-0085-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leading Pharma, LLC, Fairfield, NJ, United States |
| Recall initiated | 2017-09-28 |
| Classified | 2017-11-20 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-09-21 |
| Distributed | Nationwide (US) |
| Reason classes | labeling, potency |
| NDC | 69315-0904, 69315-0904-01, 69315-0904-05, 69315-0904-10, 69315-0905, 69315-0905-01, 69315-0905-05, 69315-0905-10, 69315-0906, 69315-0906-01, 69315-0906-05, 69315-0906-10 |
| Lot numbers | E00717 |
Product
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Reason for recall
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
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-0085-2018. 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.