CLASS III Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
BuPROPion Hydrochloride Extended-Release Tablets (XL) recalled
Actavis is recalling BuPROPion Hydrochloride Extended-Release Tablets (XL) per, distributed nationwide in the US. The recall was initiated on 31 Jul 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-855-2013
- FDA event ID
- 65881
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Jul 2013
- FDA classified
- 8 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 31 Jul 2013 | Recall initiated by company | |
| 8 Aug 2013 | Classified by FDA | +8 days |
| 14 Aug 2013 | Published in enforcement report | +6 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: Dissolution test results at 8 hour time-point were above approved specification limits.
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: Dissolution test results at 8 hour time-point were above approved specification limits.
Which lots are affected?
Lot #: CG2D18A, Exp 06/14
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.
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Other Bupropion (xl) Per recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis South Atlantic | Potency & Assay | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis South Atlantic | Potency & Assay | Nationwide |