Medications & Supplements/Prescription Drugs

Zydus Pharmaceuticals (USA) Inc: Carvedilol Tablets Recalled Due to Presence of Foreign Medication

Agency Publication Date: August 19, 2021

Summary

Zydus Pharmaceuticals (USA) Inc. has voluntarily recalled 2,880 bottles of Carvedilol (25 mg) tablets, a medication used to treat high blood pressure and heart failure. The recall was initiated after a report that two Paroxetine tablets, which is an antidepressant medication, were found inside a bottle of Carvedilol. This mix-up means consumers might accidentally ingest the wrong medication, which could lead to unexpected side effects or drug interactions. These products were distributed nationwide in the United States in 500-count bottles.

Risk

Taking Paroxetine (an antidepressant) instead of the prescribed Carvedilol (a blood pressure medication) can lead to serious health risks, including serotonin syndrome, unintended sedation, or a sudden increase in blood pressure if the intended medication is missed.

What You Should Do

Check your medication bottle to see if it is Carvedilol Tablets, USP 25 mg, sold in 500-count white plastic bottles.
Verify the identifying codes on the label: look for NDC 68382-095-05, lot number Z006279, and an expiration date of 12/31/2022.
Inspect the tablets inside the bottle; if you notice any tablets that look different from the rest or appear to be a different medication, do not consume them.
Contact your healthcare provider or pharmacist immediately for guidance if you suspect you have an affected bottle or if you have experienced any unusual symptoms.
Return any unused or affected product to the pharmacy where you purchased it for a refund.
Contact Zydus Pharmaceuticals (USA) Inc. at their Pennington, New Jersey office for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy return

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

Affected Products

Product: Carvedilol Tablets, USP 25 mg (500 Tablets bottles)

Model:

NDC 68382-095-05

Recall #: D-0753-2021

Lot Numbers:

Z006279 (exp 12/31/2022)

Date Ranges: December 31, 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88482

Status: Resolved

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: pharmacies nationwide

Manufactured In: India, United States

Units Affected: 2880 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 · 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.

Summary

What You Should Do

Check your medication bottle to see if it is Carvedilol Tablets, USP 25 mg, sold in 500-count white plastic bottles.

Verify the identifying codes on the label: look for NDC 68382-095-05, lot number Z006279, and an expiration date of 12/31/2022.

Inspect the tablets inside the bottle; if you notice any tablets that look different from the rest or appear to be a different medication, do not consume them.

Contact your healthcare provider or pharmacist immediately for guidance if you suspect you have an affected bottle or if you have experienced any unusual symptoms.

Return any unused or affected product to the pharmacy where you purchased it for a refund.

Contact Zydus Pharmaceuticals (USA) Inc. at their Pennington, New Jersey office for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.