CLASS III Drug recall · Reported 10 Oct 2012 · FDA Enforcement Report
buPROPion Hydrochloride Extended-Release Tablets (XL) recalled
McKesson Packaging Services is recalling buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD (10 x per, distributed nationwide in the US. The recall was initiated on 29 Mar 2012 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-002-2013
- FDA event ID
- 63127
- Recalling firm
- McKesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Mar 2012
- FDA classified
- 1 Oct 2012
- Reported
- 10 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 29 Mar 2012 | Recall initiated by company | |
| 1 Oct 2012 | Classified by FDA | +186 days |
| 10 Oct 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
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, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Which lots are affected?
Lot #: 0075375, 0074584, Exp 08/12
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 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.
Other products in this recall event
1 other product · FDA event 63127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | McKesson Packaging Services | Potency & Assay | Nationwide |
More recalls from McKesson Packaging Services
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 120 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem CD (Diltiazem Hydrochloride Extended-Release recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg UD recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
Other Bupropion (xl recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | buPROPion HCl ER (XL), Tablet, 150 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | McKesson Packaging Services | Potency & Assay | Nationwide |