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Lower risk Drug recall · FDA · Published September 15, 2025

Graviti Bupropion XL 300mg Tablets Recall: Failed Tablet Specifications

Graviti Pharmaceuticals recalls 300mg Bupropion XL tablets due to failed tablet specifications. This Rx-only medication may not meet quality standards. Consumers should contact the manufacturer for details.

🇺🇸 FDA recall #D-0037-2026DrugGraviti ›
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Contact the company

Recalling firmGraviti Pharmaceuticals Private LimitedE & 621 Patancheru Mandal, Isnapur Village Rd; Survey No 621 · Hyderabad, India
✎ GovInfoNow plain-language explainer

What happened, in plain English

Graviti Pharmaceuticals is recalling 300mg Bupropion Hydrochloride Extended-Release Tablets (XL) because of failed tablet specifications. This means the tablets may not meet quality standards, which could affect safety and effectiveness. Read more at govinfonow.com/recall/31783-graviti-bupropion-xl-300mg-tablets-recall-failed-tablet-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/31783-graviti-bupropion-xl-300mg-tablets-recall-failed-tablet-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0037-2026

Cite this page

“Graviti Bupropion XL 300mg Tablets Recall: Failed Tablet Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31783-graviti-bupropion-xl-300mg-tablets-recall-failed-tablet-specifications. Based on FDA recall #D-0037-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0037-2026%22&limit=1).

Why it’s dangerous

The tablets failed to meet specified quality standards, which could lead to inconsistent drug release or effectiveness. However, the recall does not indicate a risk of serious injury or death in normal use.

Who’s affected

Prescription patients who have the 300mg Bupropion XL tablets from Graviti Pharmaceuticals. Those with the specific batch number BPB124341A are most at risk.

How to tell if you have this one

Check for the product name 'Bupropion Hydrochloride Extended-Release Tablets USP (XL)', 300mg, 30-count bottles, Rx only, with batch number BPB124341A and expiration date 10/2026.

  • Brand
    Graviti
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Graviti Pharmaceuticals for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Sep 15, 202512. FDA classified it Class II: Oct 21, 202523. Published in FDA’s Enforcement Report: Oct 29, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0037-2026 (September 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0037-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA