HYDROmorphone HCl Injection — Class I drug recall D-1444-2012
Terminated recall by Hospira Inc., reported 2012-08-15, distributed nationwide. Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled a
| Recall number | D-1444-2012 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-05-12 |
| Classified | 2012-08-07 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2015-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 223,750 prefilled |
| Reason classes | labeling, potency |
| NDC | 00409-1283, 00409-1283-03, 00409-1283-31, 00409-1304, 00409-1304-03, 00409-1304-31, 00409-1312, 00409-1312-03, 00409-1312-30, 00409-2540, 00409-2540-01, 00409-2540-11, 00409-2552, 00409-2552-01, 00409-2552-11, 00409-3356, 00409-3356-01, 00409-3356-11, 00409-3365, 00409-3365-01, 00409-3365-10, 00409-3365-11 |
| Lot numbers | 07547LL |
| Expiration dates | 2013-07-01 |
Product
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).
Reason for recall
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
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-1444-2012. 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.