CLASS III Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Aplenzin¿ (bupropion hydrobromide) recalled
Valeant Pharmaceuticals North America is recalling Aplenzin¿ (bupropion hydrobromide), extended-release tablets, 174 mg HDPE, distributed nationwide in the US. The recall was initiated on 5 Jun 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0051-2015
- FDA event ID
- 69445
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jun 2014
- FDA classified
- 28 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 5 Jun 2014 | Recall initiated by company | |
| 28 Oct 2014 | Classified by FDA | +145 days |
| 5 Nov 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Package Insert
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Aplenzin¿ (bupropion hydrobromide), extended-release tablets, 174 mg HDPE recalled?
Yes. Valeant Pharmaceuticals North America recalled Aplenzin¿ (bupropion hydrobromide), extended-release tablets, 174 mg HDPE on 5 Jun 2014. The recall is Class III and its status is Terminated. Recall number D-0051-2015.
Why was it recalled?
Labeling: Incorrect or Missing Package Insert
Which lots are affected?
Lot # 13E019P; Exp 03/17
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Valeant Pharmaceuticals North America
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl CD capsules, 360 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |