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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

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

View recall →

Drug Recall Terminated Historical recordClass II

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Recall initiated: August 13, 2021
Reported by FDA: November 3, 2021
Distribution: 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT.

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Drug Recall Terminated Historical recordClass II

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06

by Lupin Pharmaceuticals Inc.

Reason: Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Recall initiated: October 8, 2021
Reported by FDA: October 27, 2021
Distribution: Distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Recall initiated: October 5, 2021
Reported by FDA: October 27, 2021
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06

by Teva Pharmaceuticals USA

Reason: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Recall initiated: September 22, 2021
Reported by FDA: October 27, 2021
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass II

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.

by Teva Pharmaceuticals USA

Reason: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Recall initiated: September 22, 2021
Reported by FDA: October 27, 2021
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass II

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06

by Teva Pharmaceuticals USA

Reason: Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Recall initiated: September 22, 2021
Reported by FDA: October 27, 2021
Distribution: USA Nationwide

View recall →

Data last updated: September 13, 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.