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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

ALLERGAN: Viokace (pancrelipase) Tablets Recalled for Subpotency

Agency Publication Date: January 5, 2018
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Summary

Allergan is recalling 12,699 bottles of Viokace (pancrelipase) 20,880 USP units tablets because the medication is subpotent. Stability testing revealed that the enzyme profile did not meet the required specifications, meaning the drug may not be as effective as intended for patients. These prescription tablets were distributed nationwide in 100-count bottles. Consumers should contact their healthcare provider or pharmacist to discuss treatment alternatives and how to return the product.

Risk

Because the medication does not contain the expected levels of active enzymes, it may fail to properly treat pancreatic insufficiency. This can lead to the malabsorption of nutrients and related digestive complications.

What You Should Do

  1. Check your Viokace (pancrelipase) 100-count bottles for Lot # 160741A with an expiration date of 02/18.
  2. Verify the National Drug Code (NDC) 58914-117-10 is printed on the bottle label to confirm if your product is affected.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are using medication from this affected lot.
  4. Return any unused product from the recalled lot to your pharmacy for a refund.
  5. Contact the manufacturer, Allergan, for further instructions regarding the return process.
  6. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Viokace (pancrelipase) tablets, 20,880 USP units (100-count bottle)
Model:
NDC 58914-117-10
Recall #: D-0154-2018
Lot Numbers:
160741A (Exp 02/18)
Date Ranges: Expiration Date 02/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78652
Status: Resolved
Manufacturer: ALLERGAN
Sold By: Pharmacies nationwide
Manufactured In: Canada
Units Affected: 12,699 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.