Hydrocodone Bitartrate and Acetaminophen Oral Solution 7 — Class III drug recall D-1139-2017
Terminated recall by VistaPharm, Inc., reported 2017-09-20, distributed nationwide. Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead o
| Recall number | D-1139-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2017-08-17 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 3,084 bottles |
| Reason classes | labeling |
| NDC | 66689-0023-16 |
| Lot numbers | 494700 |
| Expiration dates | 2018-10 |
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
Reason for recall
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
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-1139-2017. 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.