Hydrocodone Bitartrate and Acetaminophen Oral Solution — Class III drug recall D-1430-2012
Terminated recall by Mallinckrodt Inc., reported 2012-08-08, distributed nationwide. Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate in
| Recall number | D-1430-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| 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 | 41,100 bottles |
| Reason classes | potency, specification failure |
| NDC | 00406-0375-16 |
| Lot numbers | 01/14, 0375T79384, 0375T81348, 0375U82277, 05/13, 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
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
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-1430-2012. 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.