CLASS III Drug recall · Reported 26 Oct 2022 · FDA Enforcement Report
LNK International products recalled
LNK International is recalling Recalled product, distributed nationwide in the US. The recall was initiated on 11 Oct 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0014-2023
- FDA event ID
- 90983
- Recalling firm
- LNK International, Hauppauge, NY
- Manufacturer
- Walgreen Company
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Oct 2022
- FDA classified
- 18 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 11 Oct 2022 | Recall initiated by company | |
| 18 Oct 2022 | Classified by FDA | +7 days |
| 26 Oct 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Product as listed by the FDA
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
Where it was distributed
Nationwide
Stores named: Walgreens
Questions about this recall
Why was it recalled?
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Which lots are affected?
P129910 P129911 P130240
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LNK International
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Nighttime Sleep-Aid (doxylamine succinate HCl) tablets recalled | LNK International | Other | Nationwide |
| Drug | CLASS III | Acetaminophen Extra Strength Pain Reliever / Fever Reducer recalled | LNK International | Other | PA |
| Drug | CLASS II | Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg recalledNighttime Sleep Aid | LNK International | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Aspirin Free Tension Headache recalled by LNK International | LNK International | Labeling Errors | Nationwide |
Other Acetaminophen recalls
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |