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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Viatris: Lyrica CR (pregabalin) Extended-Release Tablets Recalled for Dissolution Failure

Agency Publication Date: September 24, 2021
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Summary

Viatris is recalling 9,515 bottles of Lyrica CR (pregabalin) 330 mg extended-release tablets because the medication failed to meet dissolution specifications. This means the tablets may not release the active ingredient into the body as intended. The affected product is sold in 30-count bottles and was distributed nationwide in the United States by the Parke-Davis Division of Pfizer.

Risk

When a drug fails dissolution tests, it may release the medication too slowly or too quickly. This can lead to unpredictable levels of the medication in the bloodstream, potentially making the treatment for nerve pain or seizures less effective.

What You Should Do

  1. Check your Lyrica CR (pregabalin) 330 mg 30-count bottle for NDC 0071-1029-01.
  2. Identify if your bottle is from Lot DN5396, EP9726, or EK2417 with an expiration date of August 2022.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have an affected bottle.
  4. Return any unused tablets from the recalled lots to your pharmacy for a refund.
  5. Contact the manufacturer, Viatris, for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to pharmacy and consult healthcare provider.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lyrica CR (pregabalin) extended release tablets, 330 mg (30-count bottle)
Model:
NDC 0071-1029-01
Recall #: D-0851-2021
Lot Numbers:
DN5396 (Exp. August 2022)
EP9726 (Exp. August 2022)
EK2417 (Exp. August 2022)
Date Ranges: Expiration Date: August 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88542
Status: Resolved
Manufacturer: Viatris
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 9,515 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.