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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

Exela Pharma Sciences LLC: Diclofenac Sodium and Misoprostol Tablets Recalled for Dosage Label Mix-Up

Agency Publication Date: May 22, 2018
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Summary

Exela Pharma Sciences LLC has recalled 5,256 bottles of Diclofenac Sodium and Misoprostol Delayed Release Tablets, a prescription medication used to treat arthritis symptoms and prevent stomach ulcers. The recall was issued because bottles labeled as containing 75 mg/0.2 mg tablets actually contained a lower dosage of 50 mg/0.2 mg tablets. This mix-up means patients may receive less medication than their doctor prescribed, which could lead to ineffective treatment of their condition.

Risk

A labeling error caused lower-dose 50 mg tablets to be packaged in bottles labeled as 75 mg, which could result in a patient receiving an inadequate dose of medication to manage pain and inflammation.

What You Should Do

  1. Check your prescription bottle of Diclofenac Sodium and Misoprostol Delayed Release Tablets to see if it is a 60-count bottle with NDC 42367-111-06.
  2. Identify if your bottle is from Lot GH70154 with an expiration date of 12/18.
  3. If your medication matches this lot and NDC number, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a correct replacement.
  4. Return any unused product from this affected lot to the pharmacy where you purchased it for a refund.
  5. Contact Exela Pharma Sciences LLC or the distributor for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact 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
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg (60-count bottle)
Model:
NDC 42367-111-06
Lot Numbers:
GH70154 (Exp 12/18)
Date Ranges: Expiration 12/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79969
Status: Resolved
Manufacturer: Exela Pharma Sciences LLC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 5256 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.