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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

InvaGen Pharmaceuticals, Inc.: Bupropion HCl Extended-Release Tablets Recalled for Failed Dissolution Testing

Agency Publication Date: April 4, 2018
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Summary

InvaGen Pharmaceuticals is recalling several lots of bupropion HCl extended-release tablets (generic Wellbutrin SR) because the medication failed dissolution testing during stability checks. This means the tablets may not release the active ingredient properly over time, which can result in the medication being less effective or releasing too quickly. These prescription tablets were distributed nationwide in 100 mg and 150 mg strengths in 60-count and 100-count bottles.

Risk

If the medication does not dissolve at the required rate, the patient may receive an incorrect dose, potentially leading to a lack of therapeutic effect for the treated condition.

What You Should Do

  1. Check your prescription bottle for bupropion HCl Extended-Release Tablets, USP (SR), 100 mg (NDC 69097-877-03) with lot numbers I1606579, I1606580 (Exp. 05/2018), I1612114, or I1612115 (Exp. 11/2018).
  2. Check your prescription bottle for bupropion HCl Extended-Release Tablets, USP (SR), 150 mg (NDC 69097-878-03 or 69097-878-07) with lot numbers I1606609, I1606610 (Exp. 05/2018), I1610639 (Exp. 09/2018), I1607847, or I1607845 (Exp. 06/2018).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is part of this recall, and do not stop taking your medication until you have a replacement.
  4. Return any unused tablets from the affected lots to your pharmacy for a refund and contact InvaGen Pharmaceuticals at their distributor address (7 Oser Ave, Hauppauge, NY 11788) for further instructions.
  5. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg (60 count)
Model:
NDC 69097-877-03
Recall #: D-0618-2018
Lot Numbers:
I1606579 (Exp: 05/2018)
I1606580 (Exp: 05/2018)
I1612114 (Exp: 11/2018)
I1612115 (Exp: 11/2018)
Product: buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg (60 count)
Model:
NDC 69097-878-03
Recall #: D-0619-2018
Lot Numbers:
I1606609 (Exp. Date 05/2018)
I1606610 (Exp. Date 05/2018)
I1610639 (Exp. Date 09/2018)
Product: buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg (100 count)
Model:
NDC 69097-878-07
Recall #: D-0619-2018
Lot Numbers:
I1606610 (Exp Date 05/2018)
I1607847 (Exp Date 06/2018)
I1607845 (Exp Date 06/2018)
I1610639 (Exp Date 09/2018)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79446
Status: Resolved
Manufacturer: InvaGen Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: United States
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 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.