Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Bupropion Hydrochloride Tablets Recalled for Failed Dissolution

Agency Publication Date: October 16, 2023

Summary

Sun Pharmaceutical Industries, Inc. is recalling 144 bottles of Bupropion Hydrochloride (bupropion) Extended-Release Tablets USP (SR), 150 mg. This recall was issued because the tablets failed to meet dissolution specifications, meaning the medication may not release into the body as intended. No injuries or incidents have been reported to date regarding this specific issue.

Risk

If the medication fails to dissolve correctly, it may not be absorbed by the body at the proper rate, which could make the treatment less effective. This poses a risk that the patient's condition may not be adequately managed.

What You Should Do

This recall affects 60-count bottles of Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg (NDC 47335-737-86) distributed by Sun Pharmaceutical Industries.
Check your medication bottle for lot number HAD0360A with an expiration date of 12/2023.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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) (150 mg, 60 tablets bottle)

Variants: 150 mg, 60 tablets bottle, SR

Lot Numbers:

HAD0360A (Exp. 12/2023)

NDC:

47335-737-86

Recall #: D-0044-2024; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93166

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 144 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 · 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.

Summary

What You Should Do

This recall affects 60-count bottles of Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg (NDC 47335-737-86) distributed by Sun Pharmaceutical Industries.

Check your medication bottle for lot number HAD0360A with an expiration date of 12/2023.

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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) (150 mg, 60 tablets bottle)

Variants: 150 mg, 60 tablets bottle, SR

Lot Numbers:

HAD0360A (Exp. 12/2023)

NDC:

47335-737-86