Valeant Recalls APLENZIN Tablets Due to Missing Package Insert
Valeant Pharmaceuticals is recalling 20,499 bottles of APLENZIN (bupropion hydrobromide) 174 mg 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 the product is not likely to cause adverse health consequences. The issue is a packaging/labeling defect (missing insert) rather than a direct safety hazard like contamination or dosage error.
Plain-English summary
Valeant Pharmaceuticals North America LLC is recalling 20,499 bottles of APLENZIN (bupropion hydrobromide) extended-release tablets, 174 mg, 7-count HDPE bottles. The recall is due to incorrect or missing package inserts.
The affected product is identified by Lot # 13E019P with an expiration date of 03/17. The product was distributed nationwide. APLENZIN is a prescription-only medication manufactured by Valeant Pharmaceuticals International, Inc.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 20,499
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 (2)
- Lot # 13E019P
- Exp 03/17
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.
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