Hydrocodone Bitartrate and Acetaminophen Oral Solution — Class II drug recall D-1431-2012
Terminated recall by Mallinckrodt Inc., reported 2012-08-08, distributed nationwide. CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of the
| Recall number | D-1431-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Inc., Hobart, NY, United States |
| Recall initiated | 2012-05-25 |
| Classified | 2012-07-31 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2015-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 44,330 bottles |
| Reason classes | cgmp |
| NDC | 00406-0375-16 |
| Lot numbers | 0375P76192, 0375T80512, 0375T81209, 07/12, 08/13, 09/13 |
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Reason for recall
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
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-1431-2012. 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.