HYDROmorphone HCl Injection — Class I drug recall D-020-2013

Terminated recall by Hospira Inc., reported 2012-10-31, distributed nationwide. Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain

Recall number	`D-020-2013`
Product type	Drug
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Hospira Inc., Lake Forest, IL, United States
Recall initiated	2012-08-15
Classified	2012-10-24
Reported by FDA	2012-10-31
Terminated	2015-05-29
Distributed	Nationwide (US)
Quantity	216,880 cartridge
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	`12720LL`
Expiration dates	`2013-12-01`

Product

HYDROmorphone HCl Injection, USP, 2 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 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).

Reason for recall

Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has 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-020-2013. 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.