Akorn, Inc. recalls Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY
Akorn recalls Levetiracetam Oral Solution bottles that leak. This medication is prescription-only and may cause spills if the container is defective.
Lower-risk recall
Defective container: Customer complaints for oral solution leaking from bottles.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling prescription levetiracetam oral solution bottles that leak. This defect could lead to spills, potentially causing medication contamination or accidental ingestion of the solution. Read more at govinfonow.com/recall/36563-akorn-levetiracetam-oral-solution-leaks-recall-for-safety.
Source Summary by GovInfoNow · govinfonow.com/recall/36563-akorn-levetiracetam-oral-solution-leaks-recall-for-safety · Updated October 4, 2026 · FDA enforcement record: FDA #D-0221-2021
Cite this page
“Akorn Levetiracetam Oral Solution Leaks - Recall for Safety.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36563-akorn-levetiracetam-oral-solution-leaks-recall-for-safety. Based on FDA recall #D-0221-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0221-2021%22&limit=1).
Why it’s dangerous
The bottles leak due to a defective container. Leaking could cause spills, potentially leading to medication contamination or accidental ingestion of the solution.
Who’s affected
Prescription patients using the specific bottle sizes and lots mentioned. Those with the product may be at risk of spills or medication contamination.
How to tell if you have this one
Check for bottles labeled 'Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL)' from Akorn, Inc. with lot numbers 373859, 373863, 373865 (expiring 05/2022) or 374586 (expiring 06/2022).
- Brand
Akorn- Category
Drug
What to do — step by step
Check for Leaks
Inspect the bottle for signs of leakage. If leaking, stop using the product immediately.
Questions people ask
Is this product safe to use?
The product may leak, so it's not safe to use as intended. Check for leaks before use.
What should I do if I have this product?
If the bottle leaks, stop using it immediately. Contact Akorn for further instructions.
How can I tell if I have the recalled product?
Check the bottle label for the specific lot numbers: 373859, 373863, 373865 (expiring 05/2022) or 374586 (expiring 06/2022).
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0221-2021 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0221-2021 from Akorn. 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-0221-2021 (December 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0221-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.