Carbamazepine Oral Suspension USP — Class III drug recall D-0057-2018
Terminated recall by Precision Dose Inc., reported 2017-11-08, distributed nationwide. Subpotent Drug: low out of specification results.
| Recall number | D-0057-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Precision Dose Inc., South Beloit, IL, United States |
| Recall initiated | 2017-09-25 |
| Classified | 2017-11-01 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2018-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 801 cases |
| Reason classes | potency, specification failure |
| NDC | 68094-0301-59, 68094-0301-62 |
| Lot numbers | 500105 |
| Expiration dates | 2018-04-30 |
Product
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Reason for recall
Subpotent Drug: low out of specification results.
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-0057-2018. 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.