Valeant Recalls APLENZIN Tablets Due to Missing Package Insert
Valeant Pharmaceuticals is recalling APLENZIN (bupropion hydrobromide) extended-release tablets because the package insert is incorrect or missing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to packaging/labeling documentation.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling APLENZIN (bupropion hydrobromide) extended-release tablets, 522 mg, in 7-count and 30-count HDPE bottles. The recall is due to a labeling issue where the package insert is incorrect or missing.
The affected product is prescription-only and was distributed nationwide. The recall involves 55,650 HDPE bottles across multiple lot numbers and expiration dates ranging from 07/15 to 10/16.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 55,650
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #: a) 13E023P
- Exp. 03/16 Lot #: b) 12J063P
- Exp. 07/15 12K063P
- Exp. 09/15 12K060P
- Exp. 07/15 12M073P
- Exp. 09/15 13A036P
- Exp. 11/15 13B035P
- Exp. 11/15 13C046P
- Exp. 11/15 13D060P
- Exp. 11/15 13E030P
- Exp. 03/16 13E031P
- Exp. 03/16 13F003P
- Exp. 03/16 13K034P
- Exp. 03/16 14A001P
- Exp. 10/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Valeant Pharmaceuticals North America LLC
See all →- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- LowValeant Recalls Diltiazem HCl Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
- ModerateValeant Recalls Cardizem CD Capsules for Dissolution Failures
FDA (Drugs) · 2019-02-20
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateValeant Recalls Mislabelled Lodrane D Capsules Due to Incorrect Ingredient Labeling
FDA (Drugs) · 2016-06-22
- ModerateValeant Recalls Nifedipine Extended-Release Tablets Due to Dissolution Failures
FDA (Drugs) · 2015-06-17
- LowVaseretic Tablets Recalled for Incorrect Package Insert Version
FDA (Drugs) · 2014-10-22
- LowLupin Recalls Paroxetine Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-07-19
- ModerateVenlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification
FDA (Drugs) · 2025-01-29
- LowMcKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2012-10-10