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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

VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH 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

TOBRAMYCIN FORTIFIED 15MG/ML OPH 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

THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTHENOL/PYRIDOXINE 50MG/1MG/100MG/3MG/2MG/ML (30ML 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

TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) 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

SCOPOLAMINE HYDROBROMIDE 0.25% OPH 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

PHENOL 10% (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

PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 11.8MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.2MCG/19.29MG/1.22MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.5MCG/24MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 40MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.8MCG/17.44MG/0.64MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.9MCG/17.64MG/0.59MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/15MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 70MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 8.3MCG/25MG/0.83MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 80MCG/30MG/3MG (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/12MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 40MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 50MCG/30MG/2MG/0.1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 60MCG/30MG/4MG/0.15MG/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

PE1/PAPAV/ATROP/CHLOPROM 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 7MCG/8.7MG/0.1MG/1.8MG/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

PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/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

METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/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

GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/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

GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION, 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

BSS Plus/Lidocaine Opth 1% (1ML syringe) 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

Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, 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

Acetylcysteine 10% Ophthalmic 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 I

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130

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

Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09.

by Preferred Pharmaceuticals, Inc.

Reason: Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Recall initiated: January 16, 2023
Reported by FDA: February 1, 2023
Distribution: IN

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Drug Recall Terminated Historical recordClass III

FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.

by OurPharma LLC

Reason: Short Fill: Underfilled units.
Recall initiated: January 13, 2023
Reported by FDA: February 1, 2023
Distribution: IL and MO

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Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.

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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Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.

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.