Valproic Acid Oral Solution USP — Class II drug recall D-0816-2021
Completed recall by Morton Grove Pharmaceuticals, Inc., reported 2021-09-29, distributed nationwide. CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with mic
| Recall number | D-0816-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, United States |
| Recall initiated | 2021-09-03 |
| Classified | 2021-09-20 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN |
| Quantity | 38,748 bottles |
| Reason classes | microbial contamination, cgmp |
| NDC | 60432-0621-16 |
| Lot numbers | UV1159 |
Product
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
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-0816-2021. 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.