Pfizer Recalls Viracept Tablets Due to Incorrect Expiration Date Labeling
Pfizer is recalling Viracept (nelfinavir mesylate) tablets because some bottles were labeled with an incorrect expiration date of 11/2016 instead of 09/2016.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
Pfizer Inc. is recalling Viracept (nelfinavir mesylate) tablets, 625 mg, 120-count bottles. The recall involves Lot H45241, which was distributed nationwide and in Puerto Rico.
The recall was initiated because the bottles were labeled with an incorrect expiration date of 11/2016. The correct expiration date for this lot is 09/2016. This is a labeling error regarding the product's shelf life.
Consumers who have this specific lot of Viracept should stop using it and contact their healthcare provider or pharmacist for further instructions. The product is a prescription medication used for the treatment of HIV.
The recalled product
- Product
- VIRACEPT (NELFINAVIR MESYLATE)
- Brand
- VIRACEPT
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Antiretroviral
- Hazard
- Affected units
- 1,200
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 (2)
- Lot H45241
- exp. 11/16
UPCs (1)
- 0363010010309
Distribution
Related recalls
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- LowPfizer Recalls Zarontin Capsules Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2019-10-02
- LowPfizer Recalls Ethosuximide Capsules Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2019-10-02
- LowPfizer Recalls Premarin Tablets Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2016-10-05
- ModeratePrescription Drug Recall: Incorrect Expiration Date on MEKTOVI Labels
FDA (Drugs) · 2023-04-19
- SevereAidapak Recalls Perphenazine Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-29
- LowAurobindo Recalls Simvastatin Tablets Due to Incorrect Lot and Expiration Dates
FDA (Drugs) · 2019-09-04