Skip to content
Get alerts
GovInfoNow
Unrated Drug recall · FDA · Published July 20, 2022

AvKare Recalls Lamotrigine 100mg Due to Label Error

AvKare recalls 8,328 bottles of Lamotrigine Tablets USP 100 mg due to labeling errors regarding declared strength. Check your lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1329-2022DrugAvKare ›
Take action

Contact the company

Recalling firmAVKARE Inc.615 N 1st St · Pulaski, TN 38478-2403
✎ GovInfoNow plain-language explainer

AvKare Inc. is recalling 8,328 bottles of Lamotrigine Tablets, USP 100 mg because the label contains an error regarding the declared strength. The affected products are prescription-only and were distributed nationwide within the United States. This is classified as a Class III recall. Read more at govinfonow.com/recall/34399-avkare-recalls-lamotrigine-100mg-due-to-label-error.

Source Summary by GovInfoNow · govinfonow.com/recall/34399-avkare-recalls-lamotrigine-100mg-due-to-label-error · Updated October 10, 2026 · FDA enforcement record: FDA #D-1329-2022

Cite this page

“AvKare Recalls Lamotrigine 100mg Due to Label Error.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34399-avkare-recalls-lamotrigine-100mg-due-to-label-error. Based on FDA recall #D-1329-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1329-2022%22&limit=1).

AvKare Inc. recalled Lamotrigine Tablets, USP 100 mg, 1000-count bottles due to labeling errors regarding declared strength, according to the FDA on July 20, 2022.

How to tell if you have it

  • Lamotrigine Tablets, USP 100 mg
  • 1000-count bottles
  • NDC 42291-367-10
  • UPC 3 42291 36710 4
  • Lot #: 42581 Exp. 12/2024
  • Lot #: 42484 Exp. 11/2024
  • Lot #: 41204 Exp. 05/2024
  • Lot #: 38723 Exp. 02/2023
  • Lot #: 37623 Exp. 10/2022

The hazard

The recall addresses labeling errors on the declared strength of the Lamotrigine Tablets, USP 100 mg.

Context

GovInfoNow's records show AvKare Inc. has 21 other recalls on record since Feb. 27, 2015. Other recent recalls include AVKARE Phytonadione Tablets (June 9, 2021), AVKARE TraZODONE 100mg Tablets (Dec. 7, 2020), and AVKARE Mesalamine Tablets (Oct. 30, 2020). Other recent recalls of similar products include American Regent Levocarnitine Injection (April 16, 2026), AvKARE Amantadine Capsules (Feb. 13, 2026), and AvKARE Rosuvastatin Tablets 10mg (Dec. 31, 2025).

How to tell if you have this one

Look for Lamotrigine Tablets, USP 100 mg in 1000-count bottles manufactured by AvKare Inc. of Pulaski, TN. Check the NDC 42291-367-10 and UPC 3 42291 36710 4. Verify if your bottle has one of these lot numbers: 42581 (Exp. 12/2024), 42484 (Exp. 11/2024), 41204 (Exp. 05/2024), 38723 (Exp. 02/2023), or 37623 (Exp. 10/2022).

  • Brand
    AvKare
  • Product
    Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your Lamotrigine bottle matches the recalled lot numbers and expiration dates listed in the record.

  2. Contact Your Pharmacist

    If you have a recalled bottle, consult your pharmacist or healthcare provider for guidance on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Jul 20, 202212. FDA classified it Class III: Aug 8, 202223. Published in FDA’s Enforcement Report: Aug 17, 202234. FDA terminated the recall: Sep 30, 2024420222024
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How many bottles are being recalled?

A total of 8,328 bottles are included in this recall.

Similar recalls

American Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, IncPreferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.Northstar Rx Recalls Tretinoin Cream Due to Impurities
SUN PHARMACEUTICAL INDUSTRIES INCApothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk
Apothecary Pharma LLC

Latest drug recalls

Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex · September 23, 2026Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx
Cipla USA · September 18, 2026Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc.,
Ajanta Pharma · September 17, 2026Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company recalls Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with
Insight Pharmaceuticals · September 15, 2026K.C. Pharmaceuticals, Inc. recalls Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO
Leader / TopCare / Crocodile Tears · September 11, 2026Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater,
Amneal Pharmaceuticals · September 8, 2026

Keep exploring

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-1329-2022 (July 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1329-2022 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 10, 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