Lorazepam Oral Concentrate — Class I drug recall D-0120-2018
Terminated recall by Amneal Pharmaceuticals of New York, LLC, reported 2017-12-27, distributed nationwide. Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
| Recall number | D-0120-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY, United States |
| Recall initiated | 2017-08-03 |
| Classified | 2017-12-20 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2022-09-07 |
| Distributed | Nationwide (US) |
| Quantity | 136,376 bottles |
| NDC | 65162-0687, 65162-0687-84 |
| Lot numbers | 06876016A, 06876017A, 06876018A, 06876019A, 06876020A, 06876021A, 06876022A, 06876023A, 06876024A, 06876025A, 06877001A, 06877002A, 06877003A |
| Expiration dates | 2018-08, 2018-09, 2018-11, 2018-12, 2019-02, 2019-03 |
Product
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
Reason for recall
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
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-0120-2018. 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.