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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 Bupropion Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: May 23, 2023
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Summary

Sun Pharmaceutical Industries Inc. has voluntarily recalled 5,344 bottles of bupropion hydrochloride extended-release (SR) tablets (150 mg), a prescription medication used to treat depression. The recall was issued because the tablets failed dissolution testing during stability checks, which means the medication might not release into the body as intended. No incidents or injuries have been reported, and the products were distributed to pharmacies across the United States.

Risk

Failed dissolution means the drug may not be absorbed properly by the body, which could result in the treatment being less effective than prescribed. While no injuries have been reported, inconsistent drug release can interfere with the management of medical conditions.

What You Should Do

  1. The recalled products are 60-count bottles of bupropion hydrochloride extended-release tablets (SR), 150 mg, distributed by Sun Pharmaceutical Industries, Inc. (NDC 47335-737-86).
  2. Check the label of your prescription bottle for lot numbers HAC2240A (Expiration 05/2023) or HAC3162A (Expiration 07/2023).
  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 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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: buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg (60 Tablets)
Variants: 150 mg, 60 Tablets
Lot Numbers:
HAC2240A (Exp 05/2023)
HAC3162A (Exp 07/2023)
NDC:
47335-737-86

Quantity affected: 5,344 bottles. Manufactured by Sun Pharmaceutical Industries Limited, Gujrat, India; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92289
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 5,344 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.