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Lower risk Drug recall · FDA · Published July 7, 2021

LNK International Acetaminophen Tablets Recalled for Incorrect Labeling

LNK International recalls 500mg acetaminophen tablets labeled as enteric coated but not actually coated due to labeling error. Consumers should check product details and contact the manufacturer for guidance.

🇺🇸 FDA recall #D-0665-2021DrugLNK International ›
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Contact the company

Recalling firmLNK International, Inc.55 Arkay Dr · Hauppauge, NY 11788-3707
✎ GovInfoNow plain-language explainer

LNK International has recalled a specific acetaminophen pain and fever relief product because its label incorrectly states it's enteric coated when it's not. This labeling error means consumers might be using a product that doesn't have the intended protective coating, but it doesn't pose a safety risk. Read more at govinfonow.com/recall/36100-lnk-international-acetaminophen-tablets-recalled-for-incorrect-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/36100-lnk-international-acetaminophen-tablets-recalled-for-incorrect-labeling · Updated August 18, 2026 · FDA enforcement record: FDA #D-0665-2021

Cite this page

“LNK International Acetaminophen Tablets Recalled for Incorrect Labeling.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36100-lnk-international-acetaminophen-tablets-recalled-for-incorrect-labeling. Based on FDA recall #D-0665-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0665-2021%22&limit=1).

The FDA announced on July 7, 2021, that LNK International, Inc. is recalling Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer due to labeling errors where tablets were marked as enteric coated when they are not. The agency classified the recall as Class III.

How to tell if you have it

  • Brand: LNK International
  • Product: Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each
  • NDC: 46122-649-71
  • Lot #: P120999
  • Expiration Date: 07/31/2022
  • Quantity: 8,472 bottles

The hazard

According to the FDA, the primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'.

Context

GovInfoNow's records show LNK International, Inc. has 5 other recalls on record since July 18, 2012. Other recent recalls of similar products include Kirkland Severe Cold & Flu Recall (Nov. 14, 2024), LNK Walgreens Sinus Relief Product Mislabeled as Decongestant-Free (Oct. 11, 2022), and LNK Nighttime Sleep-Aid Tablets: Incorrect Labeling Risk (Aug. 4, 2022). Other recent recalls of similar products include American Regent Levocarnitine Injection Recall (April 16, 2026), American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026), and Nephron Albuterol Inhaler: Illegible Label Hazard (March 17, 2026).

How to tell if you have this one

Check for the product name 'Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer', 50 tablets of 500 mg each, with the lot number P120999 and expiration date 07/31/2022. The product was distributed by Amerisource Bergen.

  • Brand
    LNK International
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number P120999 and expiration date 07/31/2022 on the packaging.

Where it went and when

Where it was distributed

Distributed in Pennsylvania.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Distributed in PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Pennsylvania.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Jul 7, 202112. FDA classified it Class III: Jul 16, 202123. Published in FDA’s Enforcement Report: Jul 28, 202134. FDA terminated the recall: May 4, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0665-2021 (July 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0665-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA