Phenobarbital Tablets (C. O. Truxton) – Label Mixup (2017)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
Brand
C. O. Truxton
Lot Codes / Batch Numbers
a) Lot # 70989A, Exp. 02/18, Lot # 70973A, Exp. 01/18 b) Lot # 70973A, Exp. 01/18, Lot # H15A76, Exp. 02/18, Lot # 71346A, Exp. 12/19, Lot # 70989A, Exp. 02/18
Products Sold
a) Lot # 70989A; Exp. 02/18, Lot # 70973A; Exp. 01/18 b) Lot # 70973A; Exp. 01/18, Lot # H15A76; Exp. 02/18, Lot # 71346A; Exp. 12/19, Lot # 70989A; Exp. 02/18
C. O. Truxton is recalling Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (N due to Labeling: Label Mixup; potentially mislabeled. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Label Mixup; potentially mislabeled
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026