Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Buprenorphine and Naloxone Tablets Recalled for Foreign Substance

Agency Publication Date: October 31, 2022

Summary

Sun Pharmaceutical Industries Inc. is recalling Buprenorphine and Naloxone Sublingual Tablets (8 mg/2 mg) because of the presence of a foreign substance in the product. These tablets are used to treat opioid dependence and were sold in 30-count bottles under the brand Sun Pharmaceutical. No injuries or incidents have been reported to date, but the contamination could pose health risks to users.

Risk

The tablets may contain an unidentified foreign substance. Consuming contaminated medication can lead to unpredictable side effects, irritation, or allergic reactions.

What You Should Do

The recalled products are Sun Pharmaceutical Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, sold in 30-count bottles with NDC 62756-970-83.
Identify if your product is affected by checking the label for lot numbers DNC1129A (Expiration 06/2023) or DNC1740A (Expiration 09/2023).
If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist for guidance.
Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Buprenorphine and Naloxone Sublingual Tablets (30-count bottles)

Variants: 8 mg / 2 mg, Rx only

Lot Numbers:

DNC1129A (Exp 06/2023)

DNC1740A (Exp 09/2023)

NDC:

62756-970-83

Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512; Manufactured by Sun Pharmaceutical Industries Ltd. in Dadra, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91033

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: India, United States

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

The recalled products are Sun Pharmaceutical Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, sold in 30-count bottles with NDC 62756-970-83.

Identify if your product is affected by checking the label for lot numbers DNC1129A (Expiration 06/2023) or DNC1740A (Expiration 09/2023).

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist for guidance.

Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Buprenorphine and Naloxone Sublingual Tablets (30-count bottles)

Variants: 8 mg / 2 mg, Rx only

Lot Numbers:

DNC1129A (Exp 06/2023)

DNC1740A (Exp 09/2023)

NDC:

62756-970-83

Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512; Manufactured by Sun Pharmaceutical Industries Ltd. in Dadra, India.