CLASS III Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg recalled
Actavis is recalling BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, distributed nationwide in the US. The recall was initiated on 15 Nov 2013 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-1043-2014
- FDA event ID
- 66961
- Recalling firm
- Actavis, Parsippany, NJ
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Nov 2013
- FDA classified
- 29 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 15 Nov 2013 | Recall initiated by company | |
| 29 Jan 2014 | Classified by FDA | +75 days |
| 5 Feb 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg recalled?
Yes. Actavis recalled BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg on 15 Nov 2013. The recall is Class III and its status is Terminated. Recall number D-1043-2014.
Why was it recalled?
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Which lots are affected?
Lots: 524099M, 524100A, 521687A
Where was it sold?
Nationwide and Puerto Rico
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.
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Other Bupropion recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg recalledBupropion Hydrochloride | Graviti Pharmaceuticals Private | Other | Nationwide |
| Drug | CLASS II | buPROPion Hydrochloride Extended-release Tablets recalledBupropion Hydrochloride | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg recalledBupropion Hydrochloride | Rising Pharma Holding | Other | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg recalledBupropion Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg recalledBupropion Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |