CLASS I Drug recall · Reported 18 Jun 2014 · FDA Enforcement Report
Venlafaxine HCl Extended-Release Capsules, 150 mg Unit of Use recalled
Greenstone is recalling Venlafaxine HCl Extended-Release Capsules, 150 mg Unit of Use, distributed nationwide in the US. The recall was initiated on 6 Mar 2014 and the FDA has classified it as Class I.
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-1361-2014
- FDA event ID
- 67637
- Recalling firm
- Greenstone, Peapack, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Mar 2014
- FDA classified
- 9 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 6 Mar 2014 | Recall initiated by company | |
| 9 Jun 2014 | Classified by FDA | +95 days |
| 18 Jun 2014 | 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
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Which lots are affected?
V130014, Exp 08/15
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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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|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
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| Drug | CLASS II | sertraline HCl tablets, 25 mg recalled by Greenstone | Greenstone | Other | Nationwide |
| Drug | CLASS II | Nifedipine, extended-release tablets, 90mg recalled by Greenstone | Greenstone | Packaging Defects | Nationwide |
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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 |