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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Bupropion Hydrochloride ER Tablets Recalled for Contamination

Agency Publication Date: May 10, 2022
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Summary

Sun Pharmaceutical Industries Inc. is recalling 10,548 bottles of Bupropion Hydrochloride Extended-Release (SR) Tablets in 150 mg and 200 mg strengths. The recall was initiated after a customer found a dark, gritty substance inside a bottle, which was later identified as activated carbon that had leaked from a desiccant canister used to keep the medication dry. This recall affects various bottle sizes, including 60, 100, and 500-count containers sold at pharmacies nationwide.

Risk

The tablets may be contaminated with gritty carbon particles if the desiccant canister inside the medicine bottle breaks or leaks. While no injuries have been reported, ingesting this foreign material could cause irritation or other health issues.

What You Should Do

  1. This recall affects Sun Pharmaceutical Bupropion Hydrochloride Extended-Release Tablets, USP (SR) in 150 mg and 200 mg strengths with specific lot numbers and expiration dates.
  2. To determine if your medication is affected, check the bottle label for NDC codes 47335-737-86, 47335-737-88, 47335-737-13, or 47335-738-86 and the associated lot numbers. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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 Tablet, USP (SR), 150 mg
Variants: 150 mg, 60-count bottle, 100-count bottle, 500-count bottle
Lot Numbers:
JKX5126A (Exp 10/2022)
JKX5127A (Exp 10/2022)
JKX5128A (Exp 10/2022)
JKX5126B (Exp 10/2022)
JKX5128B (Exp 10/2022)
JKX5126C (Exp 10/2022)
JKX5127C (Exp 10/2022)
JKX5128C (Exp 10/2022)
NDC:
47335-737-86
47335-737-88
47335-737-13

Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ; Manufactured by Sun Pharmaceutical Industries Limited, Gujarat, India. Recall # D-0857-2022.

Product: buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg
Variants: 200 mg, 60-count bottle
Lot Numbers:
HAC2237A (Exp 05/2023)
NDC:
47335-738-86

Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ; Manufactured by Sun Pharmaceutical Industries Limited, Gujarat, India. Recall # D-0858-2022.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90088
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 2 products (9804 bottles; 744 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.