Lacosamide Oral Solution (Camber) – Excipient Specification Fail (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
Brand
Camber Pharmaceuticals, Inc
Lot Codes / Batch Numbers
Lot#: E222200, E222199, Exp 05/2024, E222228, Exp 06/2024
Products Sold
Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Camber Pharmaceuticals, Inc is recalling Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Ca due to Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content. 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
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
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