PlainRecalls
LowClass IIITerminated

FDA Drug recall · Reported October 26, 2022

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

Recall #
D-0014-2023
Affected scope
66,384 boxes of twenty tablets each
Initiated
October 11, 2022
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
View my saved recalls

Lnk International, Inc. recalled NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEX… - a low-severity action.

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEX… was recalled by Lnk International, Inc. in October 26, 2022. Reason: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg. Check the official notice for the remedy. Verify recall #D-0014-2023 with the FDA Drug before acting.

The recall

Lnk International, Inc. issued this low-severity FDA Drug recall-Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg.

Low
severity level
Class III
classification
October 26, 2022
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0014-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0014-2023) was formally reported on October 26, 2022, with the manufacturer initiating the action on October 11, 2022. It is classified under Low severity (Class III), with a current status of Terminated. Lnk International, Inc. is listed as the recalling firm, operating out of Hauppauge, NY. Federal records list the affected scope as 66,384 boxes of twenty tablets each.

The documented reason for this recall is: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

66,384 boxes of twenty tablets each

Related Recalls

6

5 from same agency

Product description

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com

Reason for recall

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-0014-2023
Date reported October 26, 2022
Date initiated October 11, 2022
Recalling firm Lnk International, Inc.
Firm location Hauppauge, NY
Affected scope 66,384 boxes of twenty tablets each
Distribution Nationwide

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0014-2023) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com. Recalled by Lnk International, Inc.. Units affected: 66,384 boxes of twenty tablets each.
Why was this product recalled?
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Which agency issued this recall?
This recall was issued by the FDA Drug on October 26, 2022. Severity: Low. Recall number: D-0014-2023.
Where was the recalled product distributed?
Distribution: Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0014-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →

Browse all Drugs & Medications recalls →

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 26, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.