Lower risk Drug recall · FDA · Published May 9, 2023

Sun Pharmaceutical Recalls 150mg buPROPrion XR Tablets Due to Dissolution Failure

Sun Pharmaceutical recalls 150mg buPROPrion Hydrochloride Extended-Release Tablets (NDC 47335-737-86) that failed dissolution testing during stability checks. This could affect medication effectiveness.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0761-2023Drug Sun Pharmaceutical ›

Lower-risk recall

Failed Dissolution Specifications; during stability testing

Take action

Contact the company

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way · Princeton, NJ 08540-6620

✎ GovInfoNow plain-language explainer

Sun Pharmaceutical is recalling 150mg buPROPrion XR tablets that failed dissolution testing during stability checks. This means the medication might not work as intended, so affected users should contact their doctor for alternatives. Read more at govinfonow.com/recall/33495-sun-pharmaceutical-recalls-150mg-buproprion-xr-tablets-due-to-dissolution.

Source Summary by GovInfoNow · govinfonow.com/recall/33495-sun-pharmaceutical-recalls-150mg-buproprion-xr-tablets-due-to-dissolution · Updated August 17, 2026 · FDA enforcement record: FDA #D-0761-2023

Cite this page

“Sun Pharmaceutical Recalls 150mg buPROPrion XR Tablets Due to Dissolution Failure.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33495-sun-pharmaceutical-recalls-150mg-buproprion-xr-tablets-due-to-dissolution. Based on FDA recall #D-0761-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0761-2023%22&limit=1).

Sun Pharmaceutical Industries Inc. recalled buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg due to failed dissolution specifications, according to the FDA on May 9, 2023.

How to tell if you have it

Brand: Sun Pharmaceutical
Product: buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only
NDC: 47335-737-86
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Quantity: 5,344 Bottles
Distribution: Nationwide in the U.S.A

The hazard

The recall was issued because the buPROPrion Hydrochloride Extended-Release Tablets failed dissolution specifications during stability testing.

Context

GovInfoNow's records show Sun Pharmaceutical Industries Inc. has 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include Sun Pharmaceutical Nystatin Cream Recall (Sept. 14, 2026), Sun Pharmaceutical Carbamazepine Tablets Recall (Aug. 3, 2026), and Sun Pharmaceutical Perampanel 6mg Tablets Recall (June 17, 2026).

How to tell if you have this one

Check your prescription label for 'buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only'. Look for lot numbers HAC2240A (expiring May 2023) or HAC3162A (expiring July 2023).

Brand
Sun Pharmaceutical
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Prescription
Review your prescription label for the specific lot numbers HAC2240A or HAC3162A and expiration dates.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

May 9, 2023Firm started the recall
May 23, 2023FDA classified it Class II
May 31, 2023Published in FDA’s Enforcement Report
Feb 27, 2024FDA terminated the recall

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

Similar recalls

Other Sun Pharmaceutical recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33495-sun-pharmaceutical-recalls-150mg-buproprion-xr-tablets-due-to-dissolution">Sun Pharmaceutical Recalls 150mg buPROPrion XR Tablets Due to Dissolution Failure (GovInfoNow)</a>

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-0761-2023 (May 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0761-2023 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.