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Drug company (FDA labeler)

Hikma Pharmacuticals USA USA Inc.

NDC labeler code: 0054

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
1Products (NDC)
1FDA applications
13Recalls

Prescription medicines

  • ClotrimazoleClotic (Clotrimazole) Otic Solution · 1 product

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
July 29, 2004ANDA076387 Clotrimazole
CLOTRIMAZOLE		Hikma

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2026

  1. April 7, 2026 · Class II · Ongoing · D-0526-2026 · Alendronate sodium

    This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

    Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

2024

  1. December 19, 2024 · Class III · Ongoing · D-0183-2025 · Methadone hydrochloride

    Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

    Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20

2023

  1. September 22, 2023 · Class III · Ongoing · D-0066-2024 · Methotrexate

    Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.

    Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25

2020

  1. July 22, 2020 · Class III · Terminated · D-1490-2020 · Leucovorin calcium

    Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.

    Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10

2016

  1. December 22, 2016 · Class II · Terminated · D-0437-2017 · Furosemide

    Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

    Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

  2. October 3, 2016 · Class II · Terminated · D-0008-2017 · Prednisone

    Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

    PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.

  3. May 19, 2016 · Class III · Terminated · D-1441-2016 · Oxycodone hydrochloride

    Failed Impurities/Degradation Specification; 9 month stability

    Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41

2015

  1. September 25, 2015 · Class III · Terminated · D-0011-2016 · Furosemide

    CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

    FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.

  2. September 25, 2015 · Class III · Terminated · D-0012-2016 · Furosemide

    CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

    FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.

  3. April 2, 2015 · Class II · Terminated · D-1085-2015 · Acarbose

    Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

    Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25

2014

  1. May 1, 2014 · Class II · Terminated · D-1427-2014 · Calcitriol

    Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

    Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

  2. April 4, 2014 · Class III · Terminated · D-1314-2014 · Mercaptopurine

    Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

    Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11

2013

  1. June 14, 2013 · Class III · Terminated · D-882-2013 · Prednisone

    Labeling: Missing Label; missing label on blister card

    Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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