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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

Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14

by Franck's Lab Inc dba Trinity Care Solutions

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Recall initiated: May 15, 2014
Reported by FDA: July 30, 2014
Distribution: Florida

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Drug Recall Ongoing Historical recordClass II

Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14

by Franck's Lab Inc dba Trinity Care Solutions

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Recall initiated: May 15, 2014
Reported by FDA: July 30, 2014
Distribution: Florida

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Drug Recall Ongoing Historical recordClass II

Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14

by Franck's Lab Inc dba Trinity Care Solutions

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Recall initiated: May 15, 2014
Reported by FDA: July 30, 2014
Distribution: Florida

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Drug Recall Ongoing Historical recordClass II

Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14

by Franck's Lab Inc dba Trinity Care Solutions

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Recall initiated: May 15, 2014
Reported by FDA: July 30, 2014
Distribution: Florida

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Drug Recall Ongoing Historical recordClass II

Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14

by Franck's Lab Inc dba Trinity Care Solutions

Reason: Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Recall initiated: May 15, 2014
Reported by FDA: July 30, 2014
Distribution: Florida

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Drug Recall Terminated Historical recordClass III

DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France

by Estee Lauder Inc

Reason: Stability Data Does Not Support Expiry
Recall initiated: June 6, 2014
Reported by FDA: July 30, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60

by Shamrock Medical Solutions Group LLC

Reason: Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Recall initiated: September 27, 2011
Reported by FDA: July 30, 2014
Distribution: Product was shipped to the following states: CO, MA, OH, TX & WY.

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Drug Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01

by Shamrock Medical Solutions Group LLC

Reason: Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Recall initiated: September 27, 2011
Reported by FDA: July 30, 2014
Distribution: Product was shipped to the following states: CO, MA, OH, TX & WY.

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Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01

by Shamrock Medical Solutions Group LLC

Reason: Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Recall initiated: September 27, 2011
Reported by FDA: July 30, 2014
Distribution: Product was shipped to the following states: CO, MA, OH, TX & WY.

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Drug Recall Terminated Historical recordClass I

metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01

by Shamrock Medical Solutions Group LLC

Reason: Labeling: Label Mix up; product labeled did not indicated Extended Release
Recall initiated: September 27, 2011
Reported by FDA: July 30, 2014
Distribution: Product was shipped to the following states: CO, MA, OH, TX & WY.

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Drug Recall Terminated Historical recordClass I

Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36

by Shamrock Medical Solutions Group LLC

Reason: Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Recall initiated: September 27, 2011
Reported by FDA: July 30, 2014
Distribution: Product was shipped to the following states: CO, MA, OH, TX & WY.

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Drug Recall Terminated Historical recordClass I

Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90

by Shamrock Medical Solutions Group LLC

Reason: Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Recall initiated: September 27, 2011
Reported by FDA: July 30, 2014
Distribution: Product was shipped to the following states: CO, MA, OH, TX & WY.

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Drug Recall Terminated Historical recordClass III

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Recall initiated: July 11, 2014
Reported by FDA: July 30, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.

by X-Gen Pharmaceuticals Inc.

Reason: Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Recall initiated: July 17, 2014
Reported by FDA: July 30, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70

by Pfizer Inc.

Reason: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Recall initiated: July 8, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

by CareFusion 213, LLC

Reason: Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Recall initiated: June 13, 2013
Reported by FDA: July 23, 2014
Distribution: Nationwide in U.S.

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Drug Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.

by Fougera Pharmaceuticals Inc.

Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Recall initiated: July 3, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

by Fougera Pharmaceuticals Inc.

Reason: Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Recall initiated: July 3, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.
Recall initiated: June 17, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: out of specification impurity test results.
Recall initiated: June 17, 2014
Reported by FDA: July 23, 2014
Distribution: Nationwide

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Data last updated: September 30, 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.