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Use caution Drug recall · FDA · Published June 27, 2016

Sun Pharma Recalls Bupropion SR 150mg Due to Dissolution Failure

Sun Pharmaceutical recalls 16,085 bottles of Bupropion SR 150mg tablets distributed nationwide due to failed dissolution specifications.

🇺🇸 FDA recall #D-1446-2016DrugSun Pharmaceutical ›
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Recalling firmSun Pharmaceutical Industries, Inc.270 Prospect Plains Rd · Cranbury, NJ 08512-3605
✎ GovInfoNow plain-language explainer

What happened, in plain English

Sun Pharmaceutical Industries is recalling one lot of Bupropion Hydrochloride Extended Release Tablets (SR) 150 mg because they do not meet dissolution specifications. This means the medication may not release or work as intended. The recall affects 16,085 bottles distributed nationwide. Read more at govinfonow.com/recall/42572-sun-pharma-recalls-bupropion-sr-150mg-due-to-dissolution-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/42572-sun-pharma-recalls-bupropion-sr-150mg-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-1446-2016

Cite this page

“Sun Pharma Recalls Bupropion SR 150mg Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42572-sun-pharma-recalls-bupropion-sr-150mg-due-to-dissolution-failure. Based on FDA recall #D-1446-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1446-2016%22&limit=1).

Why it’s dangerous

The tablets failed dissolution specifications, which is a quality control measure ensuring the drug releases properly in the body. If the tablets do not dissolve correctly, the patient may receive less medication than prescribed, potentially leading to inadequate treatment of their condition.

Who’s affected

People who have been prescribed Bupropion Hydrochloride Extended Release Tablets (SR) 150 mg and purchased them from the affected distribution. Individuals relying on this specific medication for their treatment are at risk of receiving ineffective doses.

How to tell if you have this one

Check if you have Bupropion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only in 60-tablet bottles. Look for NDC 47335-737-86 and Lot number JKN3477A with an expiration date of 07/2016. The product was distributed nationwide by Sun Pharmaceutical Industries, Inc.

  • Brand
    Sun Pharmaceutical
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your bottle matches NDC 47335-737-86 and Lot JKN3477A with an expiration date of 07/2016.

  2. Contact Your Pharmacist

    Speak with your pharmacist or healthcare provider to determine the next steps for replacing this medication.

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: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jun 27, 201612. FDA classified it Class III: Jul 20, 201623. Published in FDA’s Enforcement Report: Jul 27, 201634. FDA terminated the recall: Mar 27, 2018420162018
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

Similar recalls

Other Sun Pharmaceutical recalls

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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-1446-2016 (June 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1446-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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