Valproic Acid Oral Solution — Class II drug recall D-0854-2021
Terminated recall by American Health Packaging, reported 2021-10-06, distributed nationwide. CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with mic
| Recall number | D-0854-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2021-09-15 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2023-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 548 ccases |
| Reason classes | microbial contamination, cgmp |
| NDC | 60687-0262-42, 60687-0262-56 |
| Lot numbers | 1000082 |
| Expiration dates | 2022-06-30 |
Product
Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
Reason for recall
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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-0854-2021. 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.