Lacosamide Oral Solution — Class III drug recall D-0094-2023
Terminated recall by Camber Pharmaceuticals, Inc, reported 2022-12-21, distributed nationwide. Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
| Recall number | D-0094-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Camber Pharmaceuticals, Inc, Piscataway, NJ, United States |
| Recall initiated | 2022-12-06 |
| Classified | 2022-12-28 |
| Reported by FDA | 2022-12-21 |
| Terminated | 2024-03-15 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 31722-0627, 31722-0627-26, 31722-0627-46 |
| Lot numbers | E222199, E222200, E222228 |
| Expiration dates | 2024-05, 2024-06 |
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
Reason for recall
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0094-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.