CLASS III Drug recall · Reported 21 Dec 2022 · FDA Enforcement Report
Lacosamide Oral Solution, USP, CV, 10mg/mL recalled
Camber Pharmaceuticals is recalling Lacosamide Oral Solution, USP, CV, 10mg/mL, distributed nationwide in the US. The recall was initiated on 6 Dec 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0094-2023
- FDA event ID
- 91239
- Recalling firm
- Camber Pharmaceuticals, Piscataway, NJ
- Brand
- Lacosamide
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Dec 2022
- FDA classified
- 28 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 6 Dec 2022 | Recall initiated by company | |
| 21 Dec 2022 | Published in enforcement report | +15 days |
| 28 Dec 2022 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Which lots are affected?
Lot#: E222200, E222199, Exp 05/2024; E222228, Exp 06/2024
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Camber Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atovaquone Oral Suspension USP, 750 mg recalledAtovaquone | Camber Pharmaceuticals | Other Bacterial Contamination | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 25 mg recalled by Camber PharmaceuticalsLosartan Potassium | Camber Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 100 mg recalledLosartan Potassium | Camber Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 50 mg recalled by Camber PharmaceuticalsLosartan Potassium | Camber Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Lacosamide recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lacosamide Tablets, USP, C V, 100mg recalled by Annora Pharma PrivateLacosamide | Annora Pharma Private | Packaging Defects | Nationwide |
| Drug | CLASS II | Lacosamide Oral Solution, USP, 10 mg/mL recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS II | Lacosamide Tablets, 50mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lacosamide Tablets 200mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lacosamide Tablets, 100mg recalled by Glenmark PharmaceuticalsLacosamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |