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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

ALLERGAN: NORCO (Hydrocodone Bitartrate and Acetaminophen) Recalled for Labeling Error

Agency Publication Date: February 9, 2018
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Summary

Allergan is recalling 8 bottles of NORCO (hydrocodone bitartrate and acetaminophen) 10 mg/325 mg tablets. These prescription pain medications were distributed in 100-count bottles and are being recalled because the primary label does not show the required "CII" symbol, which indicates it is a Schedule II controlled substance. This error affects only a very small number of bottles distributed nationwide, and there have been no reports of injuries or quality issues with the medicine itself.

Risk

The missing "CII" label could lead to a misunderstanding of the drug's classification and the specific handling or security requirements required for controlled substances. While the medication itself is safe to use if prescribed, the labeling error fails to meet federal requirements for identifying highly regulated drugs.

What You Should Do

  1. Check your prescription bottles to see if you have NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg in 100-count bottles.
  2. Verify the bottle label for NDC 0023-6022-01 and Lot number 544821A with an expiration date of 07/19.
  3. If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on your treatment.
  4. Return any unused product from the affected lot to the pharmacy where it was purchased for a refund.
  5. Contact the manufacturer, Allergan, at their Madison, New Jersey headquarters or through your pharmacist for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact 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

Contact your pharmacist for a refund or replacement medication.

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

Affected Products

Product: NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg (100-count bottles)
Model:
0023-6022-01
Lot Numbers:
544821A (Exp 07/19)
Date Ranges: Expiration July 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79080
Status: Resolved
Manufacturer: ALLERGAN
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 8 bottles
Distributed To: Nationwide

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.