CLASS II Drug recall · Reported 29 Nov 2017 · FDA Enforcement Report
Lorazepam Tablets, USP CIV, 0.5 mg recalled by Leading Pharma
Leading Pharma is recalling Lorazepam Tablets, USP CIV, 0.5 mg, distributed nationwide in the US. The recall was initiated on 28 Sep 2017 and the FDA has classified it as Class II.
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-0085-2018
- FDA event ID
- 78471
- Recalling firm
- Leading Pharma, Fairfield, NJ
- Brand
- Lorazepam
- Manufacturer
- Leading Pharma, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2017
- FDA classified
- 20 Nov 2017
- Reported
- 29 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 28 Sep 2017 | Recall initiated by company | |
| 20 Nov 2017 | Classified by FDA | +53 days |
| 29 Nov 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Product as listed by the FDA
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Which lots are affected?
Lot #E00717
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Leading Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide | Leading Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | ClomiPRAMINE Hydrochloride Capsules, USP 25mg recalled by Leading PharmaClomipramine Hydrochloride | Leading Pharma | Potency & Assay | Nationwide |
Other Lorazepam recalls
All 17| 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 |