Novel Laboratories, Inc. recalls Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by:
Novel Laboratories recalls 5/1.5 mg hydrocodone-homatropine tablets for potential impurities. This prescription-only product was manufactured between February 2018 and April 2019. Consumers should contact the manufacturer for details.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Novel Laboratories has recalled prescription hydrocodone-homatropine tablets (5/1.5 mg) due to failed impurities and degradation specifications. This recall affects specific batches manufactured between February 2018 and April 2019. The issue could pose a risk to users if the tablets contain harmful impurities. Read more at govinfonow.com/recall/40791-novel-laboratories-recalls-hydrocodone-homatropine-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/40791-novel-laboratories-recalls-hydrocodone-homatropine-tablets-due-to-impurities · Updated October 7, 2026 · FDA enforcement record: FDA #D-0599-2018
Cite this page
“Novel Laboratories Recalls Hydrocodone-Homatropine Tablets Due to Impurities.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40791-novel-laboratories-recalls-hydrocodone-homatropine-tablets-due-to-impurities. Based on FDA recall #D-0599-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0599-2018%22&limit=1).
Why it’s dangerous
The tablets failed to meet impurities and degradation specifications, which could mean they contain harmful substances not intended in the product. This issue might affect the safety and effectiveness of the medication when taken as prescribed.
Who’s affected
Prescription users of the 5/1.5 mg hydrocodone-homatropine tablets manufactured by Novel Laboratories between February 2018 and April 2019. Individuals who have taken these tablets should contact the manufacturer for guidance.
How to tell if you have this one
Check for the NDC code 43386-118-03 and the specific batch codes listed (M16002A through S700271) on the packaging. The tablets were sold between February 2018 and April 2019.
- Brand
Novel Laboratories- Product
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by:- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 43386-118-03 and batch codes M16002A through S700271 on the packaging.
Questions people ask
Why is this product being recalled?
The product failed impurities and degradation specifications, which could mean it contains harmful substances not intended in the product.
What should I do if I have this product?
Contact Novel Laboratories for specific guidance on whether to stop using the product.
When was this product manufactured?
The product was manufactured between February 2018 and April 2019.
Contact Novel Laboratories
We’ve drafted a message you can send Novel Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0599-2018 — Novel Laboratories Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Hello, I own a Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: that is covered by recall D-0599-2018 from Novel Laboratories. 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-0599-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0599-2018 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.