Carbamazepine Oral Suspension — Class II drug recall D-1037-2017
Terminated recall by Precision Dose Inc., reported 2017-08-09, distributed in CT, OH. Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists inc
| Recall number | D-1037-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Dose Inc., South Beloit, IL, United States |
| Recall initiated | 2017-07-05 |
| Classified | 2017-07-31 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2018-03-28 |
| Distributed | CT, OH |
| Quantity | 480 |
| Reason classes | labeling |
| NDC | 68094-0301-59 |
| Lot numbers | 500326 |
| Expiration dates | 2018-06-30 |
Product
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Reason for recall
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
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-1037-2017. 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.