Phenobarbital Tablets Recalled Due to Incorrect Strength Labeling
C. O. Truxton is recalling Phenobarbital 15 mg tablets that were actually 30 mg due to a labeling error.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classified this recall as FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
C. O. Truxton is recalling specific bottles of Phenobarbital Tablets USP, 15 mg, 1000 count. The recall is due to a labeling error where bottles labeled as containing 15 mg tablets actually contained 30 mg tablets.
The affected product is identified by Lot # 70952A and an expiration date of 11/17. The product was distributed nationwide. The agency has classified this recall as Class I.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
- Manufacturer
- C. O. Truxton
- Category
- Drug — Prescription Medication
- Hazard
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 # 70952A
- Exp. 11/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by C. O. Truxton under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · C. O. Truxton
See all →- SevereC. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
FDA (Drugs) · 2017-08-30
- ModerateC. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
FDA (Drugs) · 2017-08-30
- ModerateC. O. Truxton Recalls Mislabeled Amitriptyline HCL Tablets
FDA (Drugs) · 2017-08-30
- ModerateC. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error
FDA (Drugs) · 2017-08-30
- ModeratePhenobarbital Tablets Recalled for Potential Labeling Errors
FDA (Drugs) · 2017-08-30
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- 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
- ModerateWest-Ward Recalls Phenobarbital Tablets Due to Dissolution Failure
FDA (Drugs) · 2016-11-30
- ModerateLohxa Recalls Phenobarbital Oral Solution Due to Incorrect Expiration Date
FDA (Drugs) · 2019-04-17
- HighPhenazopyridine bottles recalled due to medication mix-up error
FDA (Drugs) · 2024-06-19
- LowStat Rx USA Recalls Methocarbamol Tablets Due to Incorrect Expiration Date
FDA (Drugs) · 2013-02-13
- ModeratePhenobarbital Elixir recalled for exceeding alcohol content specification
FDA (Drugs) · 2022-05-25
- ModerateWalmart Amlodipine Tablets Recalled for Labeling Error
FDA (Drugs) · 2013-05-22