FDA Drug recall D-1431-2012
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Haze…
- FDA Drug
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Haze… by Mallinckrodt, citing CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1431-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-25 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mallinckrodt |
| Distribution | US |
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
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Identifiers
| upc | 304060375161 |
|---|---|
| code_info | Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1431-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.