CLASS II Drug recall · Reported 31 Dec 2014 · FDA Enforcement Report
Walgreens Aspirin Free Tension Headache recalled by LNK International
LNK International is recalling Walgreens Aspirin Free Tension Headache, Pain Reliever/Pain Reliever Aid, Acetaminophen &, distributed nationwide in the US. The recall was initiated on 18 Jul 2012 and the FDA has classified it as Class II.
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-0319-2015
- FDA event ID
- 62613
- Recalling firm
- LNK International, Hauppauge, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2012
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 18 Jul 2012 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +888 days |
| 31 Dec 2014 | 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
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Product as listed by the FDA
Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, Item # 427594, NDC 0363-0428-12, UPC Code 311917134925
Where it was distributed
Nationwide
Stores named: Walgreens
Questions about this recall
Why was it recalled?
Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of sucralose, which was not declared on the label.
Which lots are affected?
Lot Number P78221, expiration date 05/14; Lot Number P78222, expiration date 05/14
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 | LNK International products recalledSinus Pressure, Pain And Cough | LNK International | Labeling Errors | 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 |