Leading Pharma, LLC recalls Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004
Leading Pharma recalls 500-count lorazepam tablets labeled 0.5mg but contain 1mg. This labeling error may cause incorrect dosing. Consumers should contact the company for details.
Lower-risk recall
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Contact the company & request your remedy
What happened, in plain English
Leading Pharma is recalling 500-count lorazepam tablets that are labeled as 0.5mg but actually contain 1mg each. This labeling error could lead to incorrect dosing if taken as prescribed. Read more at govinfonow.com/recall/41161-leading-pharma-recalls-0-5mg-lorazepam-tablets-labeled-as-0.
Source Summary by GovInfoNow · govinfonow.com/recall/41161-leading-pharma-recalls-0-5mg-lorazepam-tablets-labeled-as-0 · Updated October 7, 2026 · FDA enforcement record: FDA #D-0085-2018
Cite this page
“Leading Pharma recalls 0.5mg lorazepam tablets labeled as 0.5mg but contain 1mg.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41161-leading-pharma-recalls-0-5mg-lorazepam-tablets-labeled-as-0. Based on FDA recall #D-0085-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0085-2018%22&limit=1).
Why it’s dangerous
The tablets are labeled as 0.5mg but contain 1mg of lorazepam. This labeling error means that if taken as prescribed, the dose could be twice as high as intended, potentially causing side effects or overdose.
Who’s affected
People who have the 500-count lorazepam tablets labeled as 0.5mg but contain 1mg each. Those who take these tablets for medical purposes are at risk of incorrect dosing.
How to tell if you have this one
Check for the 500-count bottle labeled as 0.5mg with NDC 69315-904-05 and lot number E00717. The product is sold under the brand name Lorazepam.
- Brand
Leading Pharma- Category
Drug
What to do — step by step
Check Product Label
Look for the label that states 0.5mg but contains 1mg of lorazepam.
Questions people ask
Why is this product being recalled?
The product was recalled because the tablets are labeled as 0.5mg but contain 1mg of lorazepam, which could lead to incorrect dosing.
What should I do if I have this product?
The official recall notice does not specify a remedy, so contact Leading Pharma directly for further instructions.
Is there a risk of serious injury from this product?
The recall is for a labeling error that could cause incorrect dosing, but the official notice does not indicate a risk of serious injury.
Contact Leading Pharma
We’ve drafted a message you can send Leading Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0085-2018 — Leading Pharma Leading Pharma Hello, I own a Leading Pharma that is covered by recall D-0085-2018 from Leading Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0085-2018 (September 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0085-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.