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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

by Pharmacy Innovations

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01

by Pfizer Inc.

Reason: Presence of Particulate Matter: Glass particulate matter detected in injectable.
Recall initiated: December 22, 2022
Reported by FDA: February 1, 2023
Distribution: USA nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5

by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Recall initiated: December 6, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3

by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Recall initiated: December 6, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940

by Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Recall initiated: December 6, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.

by Spectrum Laboratory Products, Inc.

Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Recall initiated: December 19, 2022
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA, Puerto Rico and Canada

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Drug Recall Terminated Historical recordClass II

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.

by Nephron Sc Inc

Reason: CGMP Deviations: potential for trace amounts of product carryover.
Recall initiated: January 12, 2023
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.

by Nephron Sc Inc

Reason: CGMP Deviations: potential for trace amounts of product carryover.
Recall initiated: January 12, 2023
Reported by FDA: February 1, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9

by Nephron Sc Inc

Reason: Short Fill
Recall initiated: January 13, 2023
Reported by FDA: February 1, 2023
Distribution: Nationwide within the United States including Puerto Rico. Guatamala

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Drug Recall Terminated Historical recordClass II

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4

by Nephron Sc Inc

Reason: Short Fill
Recall initiated: January 13, 2023
Reported by FDA: February 1, 2023
Distribution: Nationwide within the United States including Puerto Rico. Guatamala

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Drug Recall Terminated Historical recordClass III

Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03

by Lupin Pharmaceuticals Inc.

Reason: Subpotent Drug: Low assay result observed during long-term stability testing.
Recall initiated: January 20, 2023
Reported by FDA: February 1, 2023
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.

by Ascend Laboratories, LLC

Reason: Failed Dissolution Specification
Recall initiated: January 5, 2023
Reported by FDA: February 1, 2023
Distribution: Nationwide and Puerto Rico

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Data last updated: September 12, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.