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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bupropion Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: December 2, 2023
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Summary

Sun Pharmaceutical Industries Inc. is recalling 2,016 bottles of Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg. This prescription medication, which is used to treat depression, is being recalled because it failed dissolution testing, meaning the tablets may not release the medication at the correct rate. No injuries or incidents have been reported in connection with this recall.

Risk

When a medication fails to dissolve as specified, the patient may not receive the intended dose at the proper time, which can lead to ineffective treatment of their medical condition.

What You Should Do

  1. This recall affects 60-count bottles of buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg distributed by Sun Pharmaceutical Industries, Inc. (NDC 47335-738-86).
  2. Check your prescription bottle for lot number HAD0630A with an expiration date of January 2024 (1/2024).
  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 Sun Pharmaceutical Industries Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have 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: buPROPion Hydrochloride Extended-Release Tablets, USP (SR) (200 mg, 60 Tablets bottle)
Variants: 200 mg, 60 Tablets bottle, Extended-Release (SR)
Lot Numbers:
HAD0630A (Exp 1/2024)
NDC:
47335-738-86

Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Limited, Gujarat, India

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93472
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 2016 Bottles
Distributed To: Nationwide

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.