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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

LUPIN SOMERSET: Hydrocodone and Acetaminophen Tablets Recalled for Missing Labels

Agency Publication Date: May 30, 2018
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Summary

Lupin Somerset is recalling 1,672 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP (5 mg/325 mg), a prescription pain medication. These 1000-count bottles are being recalled because they were distributed without a label, which means critical dosage and safety information is missing from the container. Consumers should contact their healthcare provider or pharmacist immediately to discuss their medication and ensure they have the correct product.

Risk

A missing label on a prescription drug prevents users and healthcare providers from verifying the medication's name, strength, and expiration date, which can lead to medication errors or the accidental use of incorrect dosages.

What You Should Do

  1. Check your medication bottles for Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg in 1000-count containers produced by Novel Laboratories, Inc.
  2. Identify if your bottle is part of the affected lot by looking for Lot Number S800257 with an expiration date of 01/20.
  3. Verify the UPC code 343386356102 and NDC 43386-356-10 on any available packaging or pharmacy records.
  4. If you have a bottle that is missing a label or matches these identifiers, contact your healthcare provider or pharmacist immediately for guidance on how to safely proceed with your treatment.
  5. Return any unused or incorrectly labeled product to the pharmacy where you purchased it for a refund and further instructions.
  6. Contact the manufacturer, Lupin Pharmaceuticals, for more information regarding this recall.
  7. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Consult healthcare provider and return product to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg (1000-count bottle)
Model:
NDC 43386-356-10
UPC Codes:
343386356102
Lot Numbers:
S800257 (Exp. 01/20)
Date Ranges: Exp. 01/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80187
Status: Resolved
Manufacturer: LUPIN SOMERSET
Sold By: pharmacies
Manufactured In: United States
Units Affected: 1,672 (1000-count) bottles
Distributed To: Ohio

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.