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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

SUN PHARMACEUTICAL INDUSTRIES INC: Venlafaxine Tablets Recalled Due to Mixed Dosage Strengths

Agency Publication Date: August 6, 2021
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Summary

Approximately 2,856 bottles of Venlafaxine (50 mg), a prescription antidepressant, have been recalled because some bottles may contain incorrect tablets of a lower strength (37.5 mg). This error means patients could unknowingly receive an incorrect dose of their medication, which may lead to a recurrence of symptoms or withdrawal effects. The affected products were manufactured for Northstar Rx LLC and distributed in bottles of 100 tablets. Consumers should immediately check their medication bottles and contact their healthcare provider to ensure they are taking the correct dosage.

Risk

Taking a lower dose of Venlafaxine than prescribed can result in the return of depression or anxiety symptoms and may cause physical withdrawal symptoms. There is a risk of therapeutic failure if a patient unknowingly consumes the 37.5 mg tablets instead of the prescribed 50 mg tablets.

What You Should Do

  1. Check your prescription bottle for Venlafaxine Tablets, USP 50 mg, 100-count bottles with NDC 16714-657-01.
  2. Verify the lot number and expiration date on the side of the label; this recall specifically affects lot AVK1175A with an expiration date of 9/2023.
  3. Inspect the tablets inside the bottle; if any tablets appear different from the rest or you suspect they are the wrong strength, do not take them.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a correct replacement supply.
  5. Contact the manufacturer, Sun Pharmaceutical Industries Inc., at 1-800-406-7984 for further instructions on returning the affected product.
  6. Return any unused or incorrect medication to your pharmacy to receive a refund.
  7. 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Venlafaxine Tablets, USP 50 mg (100 Tablets)
Model:
NDC 16714-657-01
Recall #: D-0703-2021
Lot Numbers:
AVK1175A
Date Ranges: 9/2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88376
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Northstar Distribution Center
Manufactured In: United States, Hungary, India
Units Affected: 2856 bottles
Distributed To: Tennessee

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.