CLASS I Drug recall · Reported 28 May 2014 · FDA Enforcement Report
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg recalled
Pfizer Us Pharmaceutical Group is recalling Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, 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-1328-2014
- FDA event ID
- 67636
- Recalling firm
- Pfizer Us Pharmaceutical Group, New York, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Mar 2014
- FDA classified
- 20 May 2014
- Reported
- 28 May 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 | |
| 20 May 2014 | Classified by FDA | +75 days |
| 28 May 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
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
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
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
Which lots are affected?
Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15
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.
More recalls from Pfizer Us Pharmaceutical Group
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|---|---|---|---|---|---|
| Drug | CLASS II | Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg recalledPristiq | Pfizer Us Pharmaceutical Group | Other | Nationwide |
| Drug | CLASS III | Advil PM Caplets, (Ibuprofen recalled by Pfizer Us Pharmaceutical GroupAdvil Pm | Pfizer Us Pharmaceutical Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Aldactone (spironolactone) tablets, USP, 100 mg recalledAldactone | Pfizer Us Pharmaceutical Group | Potency & Assay | Nationwide |