Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Bupropion Hydrochloride ER Tablets Recalled by InvaGen Pharmaceuticals, Inc. Due to Failed impurities/ degradation specifications: Out-of-specification results were observed...

Date: September 6, 2018
Company: InvaGen Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact InvaGen Pharmaceuticals, Inc. directly.

Affected Products

Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

Quantity: 26,496 bottles

Why Was This Recalled?

Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals, Inc. has 11 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report