CLASS II Drug recall · Reported 2 Jul 2014 · FDA Enforcement Report
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg recalled
Pfizer Us Pharmaceutical Group is recalling Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, distributed nationwide in the US. The recall was initiated on 16 Apr 2014 and the FDA has classified it as Class II.
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-1409-2014
- FDA event ID
- 68001
- Recalling firm
- Pfizer Us Pharmaceutical Group, New York, NY
- Brand
- Pristiq
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2014
- FDA classified
- 24 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 16 Apr 2014 | Recall initiated by company | |
| 24 Jun 2014 | Classified by FDA | +69 days |
| 2 Jul 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: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Product as listed by the FDA
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Which lots are affected?
H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg recalled | Pfizer Us Pharmaceutical Group | Packaging Defects | 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 |
Other Desvenlafaxine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desvenlafaxine Extended-Release Tablets 25 mg recalledDesvenlafaxine | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |