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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/Over-the-Counter

Walgreens Sinus Pressure, Pain & Cough Recalled for Incorrect Labeling

Agency Publication Date: October 18, 2022
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Summary

Walgreens Sinus Pressure, Pain & Cough (acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl) is being recalled because the boxes are mislabeled as "Decongestant Free." The medication actually contains 5mg of Phenylephrine HCl, which is a nasal decongestant. Approximately 66,384 boxes of twenty tablets each are affected by this recall, and no injuries or incidents have been reported to date.

Risk

The mislabeling could cause consumers who need to avoid decongestants due to medical conditions to accidentally ingest Phenylephrine HCl. This poses a health risk to individuals who rely on the "Decongestant Free" claim to manage their health.

What You Should Do

  1. The recalled product is Walgreens Sinus Pressure, Pain & Cough (NDC 0363-6171-09) sold in boxes of 20 tablets. The boxes are incorrectly labeled as "Decongestant Free" but contain the active ingredient Phenylephrine HCl 5mg.
  2. Identify if your product is affected by checking the lot numbers printed on the packaging. The affected lot numbers are P129910, P129911, and P130240.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, LNK International, Inc., for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Walgreens Sinus Pressure, Pain & Cough (20 tablets)
Variants: Maximum Strength, Tablets
Lot Numbers:
P129910
P129911
P130240
NDC:
0363-6171-09

Product contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90983
Status: Resolved
Manufacturer: LNK International, Inc.
Sold By: Walgreens; walgreens.com
Manufactured In: United States
Units Affected: 66,384 boxes of twenty tablets each
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.