Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was 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'
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
46122-0649-71
Compare with the code on your package — it is the most precise check available.
Drug: Acetaminophen Category: Pain Relief & OTC Medication
- Recalling firm
- LNK International, Inc.
- NDC code
- 46122-649-71
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0665-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Acetaminophen recalls
See all
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Tylenol
Defective Container
Class II · Moderate risk
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Class II · Moderate risk
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Other recalls by LNK International, Inc.
All 2021 recalls
Class II · Moderate risk
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class II · Moderate risk
Equate Night-time Sleep Aide
Microbial contamination of non-sterile product
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.