Lorazepam Tablets Recalled Due to Incorrect Strength Labeling
Leading Pharma, LLC is recalling Lorazepam tablets labeled as 0.5 mg but containing 1 mg. The recall addresses a labeling error affecting 2,952 bottles nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a labeling error that could result in temporary or medically reversible health consequences. The hazard is a strength mislabeling (0.5 mg vs 1 mg) without reported injuries.
Plain-English summary
Leading Pharma, LLC is voluntarily recalling 2,952 bottles of Lorazepam Tablets, USP CIV, 0.5 mg, 500-count. The recall is due to a labeling error where bottles labeled as containing 0.5 mg tablets actually contained 1 mg tablets of lorazepam.
The affected product is identified by Lot #E00717 and NDC 69315-904-05. The product was distributed nationwide in the USA. Lorazepam is a prescription-only medication classified as a benzodiazepine.
Consumers and healthcare providers should check their inventory for bottles with Lot #E00717. If found, the product should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- Leading Pharma, LLC
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #E00717
UPCs (9)
- 0369315905104
- 0369315904053
- 0369315904107
- 0369315906101
- 0369315906057
- 0369315905050
- 0369315904015
- 0369315905012
- 0369315906019
Distribution
Distributed nationwide across the United States.
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