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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

Bupropion Hydrochloride Extended-Release Tablets Recalled for Quality Issues

Agency Publication Date: October 21, 2025
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Summary

Graviti Pharmaceuticals is recalling approximately 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, because the medication failed to meet the required tablet and capsule specifications. This medication, which is the generic version of Wellbutrin XL, was distributed in 30-count bottles to one distributor and 16 wholesalers and retailers across the country. The recall was initiated because the product did not meet established quality standards for these types of tablets.

Risk

Failure to meet tablet specifications can result in the medication not releasing correctly in the body, potentially leading to the patient receiving too much or too little of the drug at once.

What You Should Do

  1. Check your medication bottle for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, with NDC 16571-863-03.
  2. Verify if your bottle belongs to Batch # BPB124341A with an expiration date of 10/2026.
  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 Graviti Pharmaceuticals for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 (XL) (30-count bottle)
Variants: 300 mg
Lot Numbers:
BPB124341A (Exp 10/2026)
NDC:
16571-863-03

Distributed by Rising Phar; Manufactured by Graviti Pharmaceuticals Private Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97629
Status: Active
Manufacturer: Graviti Pharmaceuticals Private Limited
Sold By: Wholesalers; Pharmacy retailers
Manufactured In: India
Units Affected: 46,512/30 count 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.