CLASS III Drug recall · Reported 28 Jul 2021 · FDA Enforcement Report
Acetaminophen Extra Strength Pain Reliever / Fever Reducer recalled
LNK International is recalling Acetaminophen Extra Strength Pain Reliever / Fever Reducer, Enteric Coated/ 500 mg each, distributed in Pennsylvania. The recall was initiated on 7 Jul 2021 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-0665-2021
- FDA event ID
- 88244
- Recalling firm
- LNK International, Hauppauge, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jul 2021
- FDA classified
- 16 Jul 2021
- Reported
- 28 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 7 Jul 2021 | Recall initiated by company | |
| 16 Jul 2021 | Classified by FDA | +9 days |
| 28 Jul 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Product as listed by the FDA
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Where it was distributed
Distributed in PA
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Which lots are affected?
Lot # P120999, Exp 07/31/2022
Where was it sold?
Distributed in PA
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 | 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 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 |