Lannett Company, Inc. recalls HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by
Lannett recalls HydrOXYzine Hydrochloride Syrup (10mg/5mL) due to manufacturing impurities. Rx-only product distributed by Lannett Company Inc. in the US. No remedy specified in recall notice.
Recall notice
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Contact the company & request your remedy
What happened, in plain English
Lannett Company recalls HydrOXYzine Hydrochloride Syrup (10mg per 5mL) because manufacturing cleaning procedures caused unknown impurities. This prescription-only medication was distributed with specific lot numbers and expiration dates. The recall does not include a remedy for consumers. Read more at govinfonow.com/recall/39507-lann-hydroxyzine-syrup-recall-manufacturing-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39507-lann-hydroxyzine-syrup-recall-manufacturing-impurities-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0083-2019
Cite this page
“Lann: HydrOXYzine Syrup Recall - Manufacturing Impurities Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39507-lann-hydroxyzine-syrup-recall-manufacturing-impurities-risk. Based on FDA recall #D-0083-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0083-2019%22&limit=1).
Why it’s dangerous
Manufacturing cleaning procedures during production created unknown impurities in the syrup. These impurities could potentially cause health risks if the medication is taken as directed. The exact nature of the impurities and their health effects are not specified in the recall notice.
Who’s affected
Prescription patients who received the recalled HydrOXYzine syrup with lot number 1097 (expiring October 2018) are affected. Patients using this medication under a doctor's supervision are most at risk.
How to tell if you have this one
Check the label for 'HydrOXYzine Hydrochloride Oral Solution, USP' with 10mg per 5mL. Look for lot number 1097 on the container, which expires October 2018. This product was distributed by Lannett Company Inc. in the US.
- Brand
Lannett- Category
Drug
What to do — step by step
Check Product Label
Look for the lot number 1097 on the HydrOXYzine syrup container, which expires October 2018.
Questions people ask
Is there a remedy for this recall?
The recall notice does not specify any remedy for consumers.
What is the specific lot number for this recall?
Lot number 1097 (expiring October 2018) is affected.
How can I tell if I have the recalled product?
Check the label for 'HydrOXYzine Hydrochloride Oral Solution, USP' with 10mg per 5mL and lot number 1097.
Contact Lannett
We’ve drafted a message you can send Lannett to request your refund or repair — edit it as you like.
Subject: Recall D-0083-2019 — Lannett Lannett Hello, I own a Lannett that is covered by recall D-0083-2019 from Lannett. 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-0083-2019 (October 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0083-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.