Hydrocodone Bitartrate & Acetaminophen Oral Solution 7 — Class II drug recall D-1416-2012
Terminated recall by VistaPharm, Inc., reported 2012-07-18, distributed nationwide. Impurities/Degradation Products: exceeded specification at 3 month stability testing
| Recall number | D-1416-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2012-05-30 |
| Classified | 2012-07-12 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-05-22 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 66689-0023-16, 66689-0023-50 |
Product
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Reason for recall
Impurities/Degradation Products: exceeded specification at 3 month stability testing
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-1416-2012. 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.