Amneal Lorazepam Oral Concentrate Recall: Dropper Markings May Be Incorrect
Amneal Pharmaceuticals recalls Lorazepam Oral Concentrate 2 mg/mL 30mL bottles due to potential reversed dropper markings. This could lead to incorrect dosing. Check NDC codes and expiration dates for affected lots.
Lower-risk recall
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
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What happened, in plain English
Amneal Pharmaceuticals is recalling Lorazepam Oral Concentrate 2 mg/mL 30mL bottles because the dropper measurement markings might be reversed, shifted, or missing. This could cause incorrect dosing if the medication is taken without proper measurement. Read more at govinfonow.com/recall/41415-amneal-lorazepam-oral-concentrate-recall-dropper-markings-may-be-incorrect.
Source Summary by GovInfoNow · govinfonow.com/recall/41415-amneal-lorazepam-oral-concentrate-recall-dropper-markings-may-be-incorrect · Updated October 7, 2026 · FDA enforcement record: FDA #D-0120-2018
Cite this page
“Amneal Lorazepam Oral Concentrate Recall: Dropper Markings May Be Incorrect.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41415-amneal-lorazepam-oral-concentrate-recall-dropper-markings-may-be-incorrect. Based on FDA recall #D-0120-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0120-2018%22&limit=1).
Why it’s dangerous
The dropper markings on the recalled bottles may be reversed, shifted, or missing. This could lead to taking too much or too little medication if the user tries to measure the dose using the dropper.
Who’s affected
People prescribed lorazepam who use the recalled 30mL bottles. Those who measure doses using the dropper may be at risk of incorrect dosing.
How to tell if you have this one
Check for NDC code 65162-687-84 with lots 06876016A through 06877003A and expiration dates up to 12/2018. The product is a prescription-only oral concentrate for lorazepam.
- Brand
Amneal Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 65162-687-84 and specific lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0120-2018 (August 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0120-2018 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.