Recall archive / FDA company announcement

Hikma: Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL — FDA announcement Jul 22, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jul 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL
Reason: Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).
Classification: Not supplied
Recalling firm: Hikma Pharmaceuticals PLC
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: ce51da04d2c9c57b

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE - London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).; On July 8, 2024, Hikma voluntarily initiated a retail level recall of Acetaminophen Injection 1000mg/100mL(10mg/mL), lot 24070381.; The lot being recalled was manufactured on 3/19/2024.; The affected lot number and expiration date being recalled is as follows:; The product can be identified by name and NDC and lot code, which are clearly stated on the overwrap of the product label, along with Hikma Pharmaceuticals USA Inc. name and address. Images of the labels are included below:; The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the recall on July 8, 2024, asking them to locate and remove the recalled product from distribution channels and return the recalled lot to Hikma’s recall service provider (Inmar Rx Solutions Inc.). Hikma also requested the direct customers to notify their direct retail customers to whom this affected product lot was distributed. Hikma is now extending the recall to the consumer/user level and asking customers at medical level facilities to locate and remove the recalled product from their channels and return the recalled lot.; This product lot recall is being made with the FDA’s knowledge.; NDC: \| Product Name and Strength \| Size \| Lot Number \| Expiration Date; 0143-9386-10 0143-9386-01, Individual bag overwrap \| Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL) \| 100mL bag \| 24070381 \| Sep-2025; Hikma Contact: \| Contact Information \| Areas of Support; Hikma Pharmaceuticals USA Inc, – Customer Service \| (P): (800) 631-2174 (E): [email protected] (F): (732) 542-0940 Hours of operation, M-F: 8:00am-6pm (EST) \| Recall related inquires; Inmar Rx Solutions, Inc. (Hikma 3rd Party Recall Service Provider) \| Mail to: Inmar RX Solutions, Attention recall Coordinator, 3845 Grand Lakes Way, Grand Prairie, TX 75050 (E): [email protected] (F): 1-817-868-5362 \| Product Returns

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE - London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).; On July 8, 2024, Hikma voluntarily initiated a retail level recall of Acetaminophen Injection 1000mg/100mL(10mg/mL), lot 24070381.; The lot being recalled was manufactured on 3/19/2024.; The affected lot number and expiration date being recalled is as follows:; The product can be identified by name and NDC and lot code, which are clearly stated on the overwrap of the product label, along with Hikma Pharmaceuticals USA Inc. name and address. Images of the labels are included below:; The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the recall on July 8, 2024, asking them to locate and remove the recalled product from distribution channels and return the recalled lot to Hikma’s recall service provider (Inmar Rx Solutions Inc.). Hikma also requested the direct customers to notify their direct retail customers to whom this affected product lot was distributed. Hikma is now extending the recall to the consumer/user level and asking customers at medical level facilities to locate and remove the recalled product from their channels and return the recalled lot.; This product lot recall is being made with the FDA’s knowledge.; NDC: | Product Name and Strength | Size | Lot Number | Expiration Date; 0143-9386-10 0143-9386-01, Individual bag overwrap | Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL) | 100mL bag | 24070381 | Sep-2025; Hikma Contact: | Contact Information | Areas of Support; Hikma Pharmaceuticals USA Inc, – Customer Service | (P): (800) 631-2174 (E): [email protected] (F): (732) 542-0940 Hours of operation, M-F: 8:00am-6pm (EST) | Recall related inquires; Inmar Rx Solutions, Inc. (Hikma 3rd Party Recall Service Provider) | Mail to: Inmar RX Solutions, Attention recall Coordinator, 3845 Grand Lakes Way, Grand Prairie, TX 75050 (E): [email protected] (F): 1-817-868-5362 | Product Returns

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
NDC:	Product Name and Strength	Size	Lot Number	Expiration Date
0143-9386-10 0143-9386-01, Individual bag overwrap	Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL)	100mL bag	24070381	Sep-2025

FDA company announcement, table 2
Hikma Contact:	Contact Information	Areas of Support
Hikma Pharmaceuticals USA Inc, – Customer Service	(P): (800) 631-2174 (E): [email protected] (F): (732) 542-0940 Hours of operation, M-F: 8:00am-6pm (EST)	Recall related inquires
Inmar Rx Solutions, Inc. (Hikma 3rd Party Recall Service Provider)	Mail to: Inmar RX Solutions, Attention recall Coordinator, 3845 Grand Lakes Way, Grand Prairie, TX 75050 (E): [email protected] (F): 1-817-868-5362	Product Returns

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

The product was distributed to Hikma’s direct customers nationwide. Hikma notified its direct customers as part of the recall on July 8, 2024, asking them to locate and remove the recalled product from distribution channels and return the recalled lot to Hikma’s recall service provider (Inmar Rx Solutions Inc.). Hikma also requested the direct customers to notify their direct retail customers to whom this affected product lot was distributed. Hikma is now extending the recall to the consumer/user level and asking customers at medical level facilities to locate and remove the recalled product from their channels and return the recalled lot.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Jul 22, 2024
Company announcement date: Jul 22, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.