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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

Vitamin B-Buildup 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

Taurine 100 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

Polidocanol (0.75%, 1%, 3%, and 10%) 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

PEN-DEX-CHLOR 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

MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, 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

Methylcobalamin 1 mg/ml / Folic Acid 2.5 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

Meloxicam 5 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

Lisinopril 20 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

Ketoprofen Solution 10% 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

Estradiol Cypionate 2 mg/ml Test Cyp 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

Ceftiofur GM vial 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

Buprenorphine 0.3 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

Atipamezole 10 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

Amikacin Sulfate 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 Terminated Historical recordClass III

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10

by West-Ward Pharmaceutical Corp.

Reason: Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Recall initiated: May 13, 2013
Reported by FDA: July 17, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.

by Sun Pharmaceutical Industries Inc.

Reason: Crystallization; crystallized nimodipine
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 III

Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

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

Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66

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 Ongoing Historical recordClass II

Yohimbine 10 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

Xylazine 300 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

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.