CLASS III Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
buPROPion Hydrochloride Extended-Release Tablets (XL) recalled
Actavis South Atlantic is recalling buPROPion Hydrochloride Extended-Release Tablets (XL) per, distributed nationwide in the US. The recall was initiated on 21 Aug 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-917-2013
- FDA event ID
- 66054
- Recalling firm
- Actavis South Atlantic, Sunrise, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Aug 2013
- FDA classified
- 23 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 21 Aug 2013 | Recall initiated by company | |
| 23 Aug 2013 | Classified by FDA | +2 days |
| 4 Sep 2013 | Published in enforcement report | +12 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: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
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 Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
Which lots are affected?
Lot #: CA2D14A, CA2D15A, Exp 12/13; CD2D07A, CD2D09A, CD2D10A, CD2D09B, CD2D08A, Exp 03/14; CE2D05A, CE2D06A, CE2D07A, CE2D11A, CE2D12A, CE2D10A, CE2D19A, Exp 04/14; CF2D01A, CF2D02A, CF2D03A, Exp 05/14; CG2D04A, CG2D05A, CG2D07A, CG2D09A, CG2D12A, CG2D12A, Exp 06/14; CH2D13A, CH2D14A, CH2D17A, CH2D18A, CH2D21A, Exp 07/14; CJ2D10A, CJ2D11A, Exp 08/14
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 26 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 Actavis South Atlantic
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL recalled | Actavis South Atlantic | Potency & Assay | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis South Atlantic | Potency & Assay | Nationwide |
Other Bupropion (xl) Per recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | BuPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis South Atlantic | Potency & Assay | Nationwide |