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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 Ongoing Historical recordClass II

Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Altrenogest 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Adenosine-Mono-Phosphate Injection, 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Acepromazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass II

Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL

by Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: May 29, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and PR

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Drug Recall Terminated Historical recordClass III

Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58

by Teva Pharmaceuticals USA, Inc.

Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall initiated: March 15, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

by Teva Pharmaceuticals USA, Inc.

Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall initiated: March 15, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11

by Fresenius Kabi USA, LLC

Reason: Failed Impurities/Degradation Specification
Recall initiated: May 21, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.

by Hospira Inc.

Reason: Presence of Particulate Matter: visible particles were identified floating in the primary container.
Recall initiated: May 2, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02

by Fresenius Kabi USA, LLC

Reason: Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Recall initiated: July 1, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide & Puerto Rico

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Drug Recall Terminated Historical recordClass III

Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58

by Teva Pharmaceuticals USA, Inc.

Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall initiated: March 15, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide distribution. No foreign or government accounts.

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Drug Recall Terminated Historical recordClass III

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

by Teva Pharmaceuticals USA, Inc.

Reason: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall initiated: March 15, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide distribution. No foreign or government accounts.

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Drug Recall Terminated Historical recordClass II

Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

by Clinical Specialties Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: March 20, 2013
Reported by FDA: July 10, 2013
Distribution: FL, GA and SC.

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Drug Recall Terminated Historical recordClass II

Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

by Clinical Specialties Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: March 20, 2013
Reported by FDA: July 10, 2013
Distribution: FL, GA and SC.

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Drug Recall Terminated Historical recordClass II

Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

by Clinical Specialties Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: March 20, 2013
Reported by FDA: July 10, 2013
Distribution: FL, GA and SC.

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Drug Recall Terminated Historical recordClass II

Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

by Clinical Specialties Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: March 20, 2013
Reported by FDA: July 10, 2013
Distribution: FL, GA and SC.

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Drug Recall Terminated Historical recordClass II

Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

by Clinical Specialties Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated: March 20, 2013
Reported by FDA: July 10, 2013
Distribution: FL, GA and SC.

View recall →

Data last updated: October 3, 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.