Acetaminophen Injection recall
FDA recall D-0635-2024 · initiated Jul 8, 2024
Hikma Pharmaceuticals USA Inc. recalled Acetaminophen Injection in Jul 2024 — an FDA Class I recall (D-0635-2024) because 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).
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
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)
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 31,400 bags
Details
- 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
- Recalling company
- Hikma Intl Pharms
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- OH and PR
- Initiated
- Jul 8, 2024
- FDA report date
- Aug 28, 2024
Frequently asked
- Was Acetaminophen Injection recalled?
- Hikma Pharmaceuticals USA Inc. recalled Acetaminophen Injection in Jul 2024 — an FDA Class I recall (D-0635-2024) because 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). Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Acetaminophen Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0635-2024 was: 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)
- Is a recalled Acetaminophen Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen Injection are affected?
- Distributed: OH and PR. The recall covers these lots — Lot #24070381; Exp. 09/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0635-2024.