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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 Pharma Buprenorphine Sublingual Tablets Recalled for Manufacturing Issues

Agency Publication Date: July 24, 2023
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Summary

Sun Pharmaceutical Industries Inc. is recalling 12,336 bottles of Buprenorphine Sublingual Tablets (8 mg), a prescription medication used to treat opioid use disorder. The recall was initiated due to deviations from current good manufacturing practices (CGMP), which means the product was not manufactured according to required quality standards. While no injuries or incidents have been reported, the manufacturing issues could potentially impact the quality or consistency of the medicine.

Risk

Failure to follow good manufacturing practices can result in medications that do not meet their required quality, purity, or potency standards. This may lead to the medication being less effective or having unintended quality variations.

What You Should Do

  1. This recall affects 30-count bottles of Buprenorphine Sublingual Tablets (8 mg) manufactured by Sun Pharma with NDC 62756-460-83.
  2. Check the label on your prescription bottle for lot number DND1515A with an expiration date of 08/24.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 Sublingual Tablets (30-count bottles)by Sun Pharma
Variants: 8 mg, Sublingual Tablet, Rx only
Lot Numbers:
DND1515A (Exp 08/24)
NDC:
62756-460-83

Recall Number: D-0869-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92256
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: 19 distributors nationwide
Manufactured In: United States
Units Affected: 12,336 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.