CLASS I Drug recall · Reported 27 Dec 2017 · FDA Enforcement Report
Lorazepam Oral Concentrate, USP, 2 mg/mL recalled
Amneal Pharmaceuticals of New York is recalling Lorazepam Oral Concentrate, USP, 2 mg/mL, distributed nationwide in the US. The recall was initiated on 3 Aug 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0120-2018
- FDA event ID
- 77898
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Brand
- Lorazepam
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Aug 2017
- FDA classified
- 20 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 3 Aug 2017 | Recall initiated by company | |
| 20 Dec 2017 | Classified by FDA | +139 days |
| 27 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Which lots are affected?
Lot 06876016A, 06876017A, 06876018A, Exp 08/2018; 06876019A, 06876020A, 06876021A, 06876022A, Exp 09/2018; 06876023A, Exp 11/2018; 06876024A, 06876025A, Exp 12/2018; 06877001A, 06877002A, Exp 02/2019; 06877003A, Exp 03/2019.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Lorazepam recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP, 0.5mg, Unit Dose per carton ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP 2 mg/mL vial vials recalled by Akorn | Akorn | Potency & Assay | Nationwide |