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Unrated Drug recall · FDA · Published August 23, 2021

Viatris Lyrica CR 330mg Tablets Recall: Failed Dissolution Specifications

Viatris recalls 330mg Lyrica CR extended-release tablets with failed dissolution specifications. Rx-only bottles distributed by Parke-Davis Division of Pfizer. No remedy specified in official notice.

🇺🇸 FDA recall #D-0851-2021DrugViatris ›
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Recalling firmViatris781 Chestnut Ridge Rd · Morgantown, WV 26505-2730
✎ GovInfoNow plain-language explainer

Viat:ris is recalling 330mg Lyrica CR extended-release tablets that failed dissolution tests. This means the medication may not release properly in the body, potentially affecting treatment effectiveness. The recall applies to specific lot numbers and expiration dates. Read more at govinfonow.com/recall/35888-viatris-lyrica-cr-330mg-tablets-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/35888-viatris-lyrica-cr-330mg-tablets-recall-failed-dissolution-specifications · Updated August 18, 2026 · FDA enforcement record: FDA #D-0851-2021

Cite this page

“Viatris Lyrica CR 330mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35888-viatris-lyrica-cr-330mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0851-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0851-2021%22&limit=1).

The FDA announced on August 23, 2021, that Viatris voluntarily recalled Lyrica CR (pregabalin) extended release tablets due to failed dissolution specifications. The recall involves 9,515 bottles distributed nationwide within the United States.

How to tell if you have it

  • Brand: Viatris
  • Product: Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles
  • NDC: 0071-1029-01
  • Lot codes: DN5396, EP9726, EK2417
  • Expiration date: August 2022

The hazard

The tablets failed to meet dissolution specifications. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Viatris has one other recall on record since September 13, 2021. On September 13, 2021, Viatris recalled Candesartan Cilexetil Tablets 16mg due to impurities risk. Other recent recalls of similar products include Viatris Xanax XR 3mg Tablets Recall (March 17, 2026), Teva Metoprolol Succinate Tablets Recall (January 29, 2026), and Lannett Niacin Extended-release Tablets Recall (May 27, 2026).

How to tell if you have this one

Check for Lyrica CR 330mg tablets in 30-count bottles with lot numbers DN5396, EP9726, or EK2417 and expiration date August 2022. These are prescription-only products distributed by Parke-Davis Division of Pfizer.

  • Brand
    Viatris
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your Lyrica CR 330mg tablets have the specific lot numbers DN5396, EP9726, or EK2417 with an expiration date of August 2022.

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 12 months after the firm started it.

1. Firm started the recall: Aug 23, 202112. FDA classified it Class II: Sep 24, 202123. Published in FDA’s Enforcement Report: Oct 6, 202134. FDA terminated the recall: Sep 7, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  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-0851-2021 (August 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0851-2021 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