The Recall Desk
ModerateFDA (Drugs)·D-0094-2023·Announced 2022-12-21

Lacosamide oral solution recalled for failed excipient specifications

Camber Pharmaceuticals is recalling specific lots of Lacosamide oral solution due to out-of-specification p-Hydroxybenzoic Acid content. The recall affects multiple lot numbers distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall, the lowest classification level, with no reported illnesses or injuries. The issue represents a manufacturing specification failure without confirmed safety harm, consistent with precautionary quality-control recalls.

Plain-English summary

Camber Pharmaceuticals, Inc. is recalling Lacosamide Oral Solution, USP, 10mg/mL, distributed in 200 mL bottles due to failed excipient specifications.

The recall was initiated after laboratory testing identified out-of-specification results for p-Hydroxybenzoic Acid content in the affected lot numbers: E222200 and E222199 (expiring 05/2024) and E222228 (expiring 06/2024).

The product was distributed nationwide. No illnesses or injuries have been reported. Consumers with affected lots should consult their healthcare provider or pharmacist before using the product.

The recalled product

Product
LACOSAMIDE (LACOSAMIDE)
Brand
LACOSAMIDE
Manufacturer
Camber Pharmaceuticals, Inc
Hazard
  • excipient-specification-failure

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 (5)

  • Lot#: E222200
  • E222199
  • Exp 05/2024
  • E222228
  • Exp 06/2024

UPCs (2)

  • 0331722627269
  • 0331722627467

Distribution

Distributed nationwide across the United States.