Medications & Supplements/Prescription Drugs

InvaGen Pharmaceuticals, Inc.: Bupropion Hydrochloride ER Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: September 25, 2018

Summary

InvaGen Pharmaceuticals, Inc. is recalling 26,496 bottles of Bupropion Hydrochloride ER (extended-release) Tablets, USP 150 mg, which are used to treat depression and prevent seasonal affective disorder. The recall was initiated because certain batches were found to have levels of an impurity called meta-chlorobenzoic acid that exceeded approved safety specifications during stability testing. These affected 90-count bottles were manufactured for Cipla USA Inc. and BluePoint Laboratories.

Risk

The tablets were found to have out-of-specification results for degradation impurities when the product reaches 18 months of age or older. While the risk level is considered low, consuming medication with higher-than-approved impurity levels may reduce the effectiveness of the treatment or cause unforeseen side effects over time.

What You Should Do

Check your prescription bottle to see if you have Bupropion Hydrochloride ER Tablets, USP 150 mg in 90-count bottles with NDC numbers 69097-875-05 (Cipla USA Inc.) or 68001-322-05 (BluePoint Laboratories).
Look for the following lot numbers and expiration dates on the side of the bottle: For NDC 69097-875-05, check for lots 1612130, 1612131 (Exp 11/18), 1709986 (Exp 8/19), or 1711549 (Exp 10/19).
For NDC 68001-322-05, check for lots 1701171, 1701174, 1701175, 1701176 (Exp 12/18); 1705131, 1705132, 1705133 (Exp 4/19); 1709986, 1709985 (Exp 8/19); 17110257 (Exp 9/19); 1712809, 1801041, 1801051 (Exp 12/19); or 1802283 (Exp 1/20).
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to determine if a replacement medication is necessary.
Return any unused product from the affected lots to your pharmacy to receive a refund and further instructions from the manufacturer.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmaceutical product return

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

Affected Products

Product: Bupropion Hydrochloride ER Tablets, USP 150 mg (90-count bottle)

Model:

NDC 69097-875-05

Lot Numbers:

1612130 (Exp 11/18)

1612131 (Exp 11/18)

1709986 (Exp 8/19)

1711549 (Exp 10/19)

Date Ranges: Expiration 11/18, Expiration 8/19, Expiration 10/19

Product: Bupropion Hydrochloride ER Tablets, USP 150 mg (90-count bottle) BluePoint Laboratories

Model:

NDC 68001-322-05

Lot Numbers:

1701171 (Exp 12/18)

1701174 (Exp 12/18)

1701175 (Exp 12/18)

1701176 (Exp 12/18)

1705131 (Exp 4/19)

1705132 (Exp 4/19)

1705133 (Exp 4/19)

1709986 (Exp 8/19)

1709985 (Exp 8/19)

17110257 (Exp 9/19)

1712809 (Exp 12/19)

1801041 (Exp 12/19)

1801051 (Exp 12/19)

1802283 (Exp 1/20)

Date Ranges: Expiration 12/18, Expiration 4/19, Expiration 8/19, Expiration 9/19, Expiration 12/19, Expiration 1/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80973

Status: Resolved

Manufacturer: InvaGen Pharmaceuticals, Inc.

Sold By: 14 major distributors

Manufactured In: United States

Units Affected: 26,496 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

Risk

What You Should Do

Check your prescription bottle to see if you have Bupropion Hydrochloride ER Tablets, USP 150 mg in 90-count bottles with NDC numbers 69097-875-05 (Cipla USA Inc.) or 68001-322-05 (BluePoint Laboratories).

Look for the following lot numbers and expiration dates on the side of the bottle: For NDC 69097-875-05, check for lots 1612130, 1612131 (Exp 11/18), 1709986 (Exp 8/19), or 1711549 (Exp 10/19).

For NDC 68001-322-05, check for lots 1701171, 1701174, 1701175, 1701176 (Exp 12/18); 1705131, 1705132, 1705133 (Exp 4/19); 1709986, 1709985 (Exp 8/19); 17110257 (Exp 9/19); 1712809, 1801041, 1801051 (Exp 12/19); or 1802283 (Exp 1/20).

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to determine if a replacement medication is necessary.

Return any unused product from the affected lots to your pharmacy to receive a refund and further instructions from the manufacturer.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Bupropion Hydrochloride ER Tablets, USP 150 mg (90-count bottle)

Model:

NDC 69097-875-05

Lot Numbers:

1612130 (Exp 11/18)

1612131 (Exp 11/18)

1709986 (Exp 8/19)

1711549 (Exp 10/19)

Date Ranges: Expiration 11/18, Expiration 8/19, Expiration 10/19

Product: Bupropion Hydrochloride ER Tablets, USP 150 mg (90-count bottle) BluePoint Laboratories

Model:

NDC 68001-322-05

Lot Numbers:

1701171 (Exp 12/18)

1701174 (Exp 12/18)

1701175 (Exp 12/18)

1701176 (Exp 12/18)

1705131 (Exp 4/19)

1705132 (Exp 4/19)

1705133 (Exp 4/19)

1709986 (Exp 8/19)

1709985 (Exp 8/19)

17110257 (Exp 9/19)

1712809 (Exp 12/19)

1801041 (Exp 12/19)

1801051 (Exp 12/19)

1802283 (Exp 1/20)

Date Ranges: Expiration 12/18, Expiration 4/19, Expiration 8/19, Expiration 9/19, Expiration 12/19, Expiration 1/20