Actavis Pharmaceuticals buPROPion Hydrochloride Extended Recall

Why it was recalled

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

Product description

buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217

Lot numbers, UPCs & expiration codes

Lot CB1D05A,

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-175-2013
Classification: Class III
Status: Terminated
Recall initiated: Jan 4, 2013
FDA report date: Mar 6, 2013
Quantity: 14,856 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Actavis Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-175-2013, exactly as published.

Show all FDA fields

City: Morristown
State: NJ
Status: Terminated
Country: United States
Event ID: 64317
Address: 60 Columbia Rd Bldg B
Code information: Lot CB1D05A,
Postal code: 07960-4535
Report date: Mar 6, 2013
Product type: Drugs
Recall number: D-175-2013
Classification: Class III
Recalling firm: Actavis Pharmaceuticals
Product quantity: 14,856 bottles
Termination date: Jan 13, 2014
Reason for recall: Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Voluntary / mandated: Voluntary: Firm initiated
Product description: buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Distribution pattern: Nationwide
Recall initiation date: Jan 4, 2013
Initial firm notification: Letter
Center classification date: Feb 27, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-175-2013, published Mar 6, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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