FDA Recalls Acetaminophen Injection Due to Labeling Mix-up
Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity rating of 4. The labeling error—placing a different injectable drug in Acetaminophen-labeled packaging—creates significant risk of medication administration errors that could cause serious harm.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Acetaminophen Injection, 1,000 mg per 100 mL, for intravenous use. The recall affects 31,400 bags (lot #24070381, expiration 09/30/2025) distributed to Ohio and Puerto Rico.
The recall was initiated due to a labeling error. At least one bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was discovered packaged inside an overwrap labeled as Acetaminophen Injection. Since Dexmedetomidine is a completely different medication than Acetaminophen, administering the wrong product could result in serious patient harm.
Healthcare facilities that received product from the affected lot should immediately remove all units from use and quarantine them. Verify the lot number and expiration date to identify affected inventory. Contact Hikma Pharmaceuticals or your supplier if you have questions about whether your supply is affected. Patients who may have received medication from this lot should contact their healthcare provider immediately.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injectable / Intravenous
- Affected units
- 31,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #24070381
- Exp. 09/30/2025
Distribution
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