CLASS III Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
Lorazepam, 0.5 mg tablets, 100 count, RX only recalled
Legacy Pharmaceutical Packaging is recalling Lorazepam, 0.5 mg tablets, 100 count, RX only, distributed in Indiana. The recall was initiated on 27 Mar 2013 and the FDA has classified it as Class III.
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-580-2013
- FDA event ID
- 64794
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Mar 2013
- FDA classified
- 6 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 27 Mar 2013 | Recall initiated by company | |
| 6 Jun 2013 | Classified by FDA | +71 days |
| 12 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Product as listed by the FDA
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Where it was distributed
Distribution was made to IN.
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Which lots are affected?
L-04009 Exp.11/15
Where was it sold?
Distribution was made to IN.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Legacy Pharmaceutical Packaging
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|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
| Drug | CLASS III | Metformin Hydrochloride Tablets USP, 1000 mg recalled | Legacy Pharmaceutical Packaging | Packaging Defects | AR, GA |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, IN, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | 5 states |
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 |