CLASS III Drug recall · Reported 26 Mar 2014 · FDA Enforcement Report
Venlafaxine Hydrochloride, Extended Release Capsules recalled
McKesson Packaging Services is recalling Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD- per Box (10 x, distributed nationwide in the US. The recall was initiated on 3 Mar 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-1167-2014
- FDA event ID
- 67747
- Recalling firm
- McKesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Mar 2014
- FDA classified
- 18 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 3 Mar 2014 | Recall initiated by company | |
| 18 Mar 2014 | Classified by FDA | +15 days |
| 26 Mar 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
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
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
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Which lots are affected?
Lot #: 91357
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.
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 Venlafaxine recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine | Zydus Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS III | Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine | Appco Pharma | Other | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg recalledVenlafaxine Hydrochloride | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Hydrochloride, extended-release capsules recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Venlafaxine Tablets, USP 50 mg* recalled | SUN Pharmaceutical Industries | Other | TN |