Acetaminophen Injection — Class I drug recall D-0635-2024
Ongoing recall by Hikma Pharmaceuticals USA Inc., reported 2024-08-28, distributed in OH, PR. Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an ove
| Recall number | D-0635-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2024-07-08 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | OH, PR |
| Quantity | 31,400 bags |
| Reason classes | labeling |
| NDC | 00143-9386, 00143-9386-01, 00143-9386-10 |
| Lot numbers | 24070381 |
| Expiration dates | 2025-09-30 |
Product
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
Reason for recall
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
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-0635-2024. 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.