FDA Drug recall D-0085-2018
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
- FDA Drug
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05 by Leading Pharma, citing labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0085-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-28 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Leading Pharma |
| Distribution | US |
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
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Identifiers
| ndc | 69315-904-01 |
|---|---|
| ndc | 69315-904-05 |
| ndc | 69315-904-10 |
| ndc | 69315-905-01 |
| ndc | 69315-905-05 |
| ndc | 69315-905-10 |
| ndc | 69315-906-01 |
| ndc | 69315-906-05 |
| ndc | 69315-906-10 |
| code_info | Lot #E00717 |
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-0085-2018%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.