Hetero Labs, Ltd. - Unit III recalls Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber
Hetero Labs recalls Levetiracetam Oral Solution (100 mg/mL) due to a foreign screw in the bottle. This could cause injury if the bottle breaks. Contact the manufacturer for details.
Use caution until it’s fixed
Presence of foreign substance (screw)
Contact the company & request your remedy
What happened, in plain English
Hetero Labs is recalling Levetiracetam Oral Solution bottles that may contain a foreign screw. This hazard could cause injury if the bottle breaks during use. Read more at govinfonow.com/recall/41139-hetero-labs-levetiracetam-oral-solution-recall-foreign-screw-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41139-hetero-labs-levetiracetam-oral-solution-recall-foreign-screw-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0099-2018
Cite this page
“Hetero Labs Levetiracetam Oral Solution Recall: Foreign Screw Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41139-hetero-labs-levetiracetam-oral-solution-recall-foreign-screw-hazard. Based on FDA recall #D-0099-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0099-2018%22&limit=1).
Why it’s dangerous
The bottle may contain a foreign screw that could cause the bottle to break if it's shaken or dropped. This could lead to injury from sharp fragments or the solution leaking.
Who’s affected
People who have the 16 fl oz bottle of Levetiracetam Oral Solution (100 mg/mL) prescribed by a doctor. Those with the bottle from the specified lot number and expiration date are most at risk.
How to tell if you have this one
Check for the 16 fl oz (473 mL) bottle labeled 'Levetiracetam Oral Solution, USP, 100 mg/mL'. The lot number is E170346 and expiration date is February 2019.
- Brand
Hetero Labs- Category
Drug
What to do — step by step
Check for Foreign Screw
Inspect the bottle for any visible screw or foreign object before use.
Questions people ask
Is this product safe to use?
The product may contain a foreign screw that could cause injury if the bottle breaks. Do not use until checked.
How do I know if I have the recalled product?
Check for the 16 fl oz bottle with lot number E170346 and expiration date February 2019.
What should I do if I have the recalled product?
Inspect the bottle for a foreign screw. If found, do not use and contact the manufacturer for further instructions.
Contact Hetero Labs
We’ve drafted a message you can send Hetero Labs to request your refund or repair — edit it as you like.
Subject: Recall D-0099-2018 — Hetero Labs Hetero Labs Hello, I own a Hetero Labs that is covered by recall D-0099-2018 from Hetero Labs. 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-0099-2018 (October 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0099-2018 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.