Triveen PRx RNF Capsules Recalled for Incorrect Vitamin B12 Labeling
Trigen Laboratories is recalling Triveen PRx RNF Capsules because the label lists Vitamin B12, which is not in the formulation.
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 by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding an ingredient not present in the formulation.
Plain-English summary
Trigen Laboratories, Inc. is recalling 142,732 bottles of Triveen PRx RNF Capsules, 30-count bottles, Rx only. The product is distributed nationwide. The recall involves specific lot numbers with expiration dates ranging from March 2015 to October 2015.
The recall was initiated due to a labeling error. The Supplement Facts panel on the label indicates that the product contains 12 micrograms of Vitamin B12. However, the actual formulation of the product does not contain Vitamin B12.
This is an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase.
The recalled product
- Product
- Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
- Manufacturer
- Trigen Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 142,732
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 (12)
- Lot #: 505024006
- 505024007
- Exp 03/15
- 505024008
- 505024009
- Exp 06/15
- 505024010
- Exp 08/15
- 505024011
- Exp 09/15
- and 505024012
- Exp 10/15
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
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
- SevereTG United Recalls Trigofen Drops Due to Underdosing and Dosage Errors
FDA (Drugs) · 2013-06-12
- SevereRXQ Compounding Recalls Vitamin B Complex 100 Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- LowPar Pharmaceutical Recalls Prednisone Tablets Due to Incorrect Expiration Date
FDA (Drugs) · 2020-03-25
- SevereTG United Recalls Tri-Dex PE Due to Underdosing and Dosage Errors
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Trigofen DM Drops Due to Underdosing
FDA (Drugs) · 2013-06-12
- ModerateNutrition Express Recalls Lindberg B-Complex Vitamins for Folic Acid Labeling Error
FDA (Food) · 2014-08-20