Pfizer Recalls Pristiq 50 mg Tablets Due to Foreign 100 mg Tablet
Pfizer is recalling Pristiq 50 mg extended-release tablets because a 100 mg tablet was found in a bottle labeled for 50 mg.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (wrong dosage of prescription medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Pfizer is recalling Pristiq (desvenlafaxine) 50 mg extended-release tablets. The recall was initiated because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
The affected product is Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, distributed by Wyeth Pharmaceuticals, Inc. The recall involves 220,761 bottles distributed nationwide. Specific lot codes include H74477, H74478, H74479, and H79766, with expiration dates of 03/16 and 05/16.
Consumers should check their medication for the affected lot codes and expiration dates. If the medication matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- PRISTIQ (DESVENLAFAXINE SUCCINATE)
- Brand
- PRISTIQ
- Manufacturer
- Pfizer Us Pharmaceutical Group
- Category
- Drug — Prescription Medication
- Affected units
- 220,761
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- H74477
- H74478
- Exp. 03/16
- H74479
- H79766 Exp. 05/16
UPCs (3)
- 0300081210306
- 0300081222309
- 0300081211303
Distribution
Distributed nationwide across the United States.
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