The Recall Desk

Manufacturer

Hikma Pharmaceuticals USA INC.

20 recalls in our database name Hikma Pharmaceuticals USA INC. as the manufacturing or recalling firm.

What the numbers show

Total
20
Critical
1
Severe
2
Most recent
2026-09-02

Of the 20 recalls from Hikma Pharmaceuticals USA INC. we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–20 of 20

  • ModerateFDA (Drugs)·D-0831-2026·2026-09-02

    Hikma Recalls Ramipril Capsules Due to Process Impurity

    Hikma Pharmaceuticals is recalling specific lots of Ramipril 10 mg capsules because they failed impurity specifications for dicyclohexylurea.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2026·2026-05-06

    Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results

    Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.

    Product
    ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0635-2024·2024-08-28

    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.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0392-2024·2024-03-27

    Morphine Sulfate Ampuls Recalled for Expired Filters in Cartons

    Hikma Pharmaceuticals is recalling Infumorph 200 (morphine sulfate) ampuls because the sterile filter in the carton has an earlier expiration date than the medication, potentially compromising sterility.

    Product
    INFUMORPH 200 — INFUMORPH 200 (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2023·2023-05-24

    Lorazepam injection vials recalled for elevated impurities and degradation

    Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2023·2023-01-04

    Ganciclovir injection vials contain mislabeled cladribine vials in cartons

    Hikma Pharmaceuticals recalled Ganciclovir for Injection due to a labeling error where one vial per carton was mislabeled as Cladribine Injection, creating a risk of incorrect medication administration.

    Product
    GANCICLOVIR — GANCICLOVIR (GANCICLOVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1310-2022·2022-08-17

    Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation

    Hikma Pharmaceuticals is recalling 82,700 vials of Lorazepam Injection due to failed quality specifications for impurities and degradation. Lot #070096 (expired July 2023) was distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1307-2022·2022-08-17

    Lorazepam injection vials recalled nationwide for manufacturing specification failures

    Hikma Pharmaceuticals is recalling approximately 4.7 million vials of Lorazepam injection nationwide after finding out-of-specification related compounds during quality testing. The affected lots expire between June and August 2023.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0771-2021·2021-09-01

    Bleomycin for Injection Recalled Due to Mislabeling

    Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.

    Product
    BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0169-2021·2020-12-23

    Hikma Recalls Sodium Chloride Injection Vials Due to pH Failures

    Hikma Pharmaceuticals is recalling 1.3 million vials of Sodium Chloride Injection USP 0.9% because pH test results were out of specification.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0101-2021·2020-11-25

    Hikma Recalls Sodium Chloride Injection Vials Due to pH Failures

    Hikma Pharmaceuticals is recalling specific lots of Sodium Chloride Injection USP 0.9% 2 mL vials because they failed pH specifications.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1533-2020·2020-09-02

    Hikma Recalls Buprenorphine Hydrochloride Injection Due to Low Potency

    Hikma Pharmaceuticals is recalling 97,890 vials of Buprenorphine Hydrochloride Injection because stability testing revealed the drug was sub-potent.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1308-2020·2020-06-24

    Hikma Recalls Irinotecan Hydrochloride Injection Due to Container Defect

    Hikma Pharmaceuticals is recalling 82,426 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1309-2020·2020-06-24

    Hikma Recalls Irinotecan Hydrochloride Vials Due to Container Defect

    Hikma Pharmaceuticals is recalling 17,998 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0801-2020·2020-01-29

    Hikma Recalls Methylprednisolone Sodium Succinate Injection Due to Labeling Error

    Hikma Pharmaceuticals is recalling 4,840 vials of Methylprednisolone Sodium Succinate Injection because the label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL instead of 8 mL.

    Product
    METHYLPREDNISOLONE SODIUM SUCCINATE — METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0864-2020·2020-01-22

    Hikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter

    Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0658-2020·2020-01-22

    Hikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter

    Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Hikma Pharmaceuticals

UK-headquartered pharmaceutical company

Country
United Kingdom
Founded
1978

Official website

Source: Wikidata (Q12179266), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.