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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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Showing 17,901–17,920 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML 2 ML 24 ML 3 ML 32 ML 8 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE 0.4 ML 2 ML 3 ML 5 ML 6 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE 100 ML 40 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE 0.1 ML DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE 50 ML DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML 180 MLS 240 MLS 30 ML 60 ML DEXAMETHASONE SODIUM PHOSPHATE IN BSS (P.F.) 10MG/ML (1%) INJECTABLE 1 ML DEXAMETHASONE SODIUM PHOSPHATE, 30ML VIAL** 4MG/ML INJECTABLE 30 ML DEXAMETHASONE SOLUTION - NACL, P.F. 0.1% OPHTHALMIC 15 ML DEXAMETHASONE, SDPF - (0.07ML SYRINGE, 30G, 1/2") 80MG/ML INJECTABLE 0.35 ML 0.7 ML

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML, 60 ML; CYCLOSPORINE (A) OIL SOLUTION 2% OPHTHALMIC 10 ML, 15 ML, 20 ML, 30 ML (12 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

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Drug Recall Terminated Historical recordClass II

CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

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Drug Recall Terminated Historical recordClass II

CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT 12 KIT 16 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 8 KIT CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE 0.2 ML 0.4 ML 0.6 ML 0.8 ML 1.2 ML 1.6 ML (25 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 ML; ALPROSTADIL 30MCG/ML INJECTABLE 10 ML; ALPROSTADIL 35MCG/ML INJECTABLE 10 ML; ALPROSTADIL 40MCG/ML INJECTABLE 10 ML, 10 ML, 10 VIAL, 15 ML, 2 ML, 20 ML, 3 ML, 30 ML, 40 ML, 5 ML, 50 ML, 6 ML; ALPROSTADIL 50MCG/ML INJECTABLE 10 ML, 2 ML, 20 ML, 5 ML; ALPROSTADIL 60MCG/ML INJECTABLE 20 ML; ALPROSTADIL (M) 500MCG/ML INJECTABLE 10 ML; ALPROSTADIL 100MCG/ML INJECTABLE 5 ML; ALPROSTADIL, STERILE 1,000MCG/ML GEL 10 ML, 12 ML, 20 ML, 3 ML, 30 ML, 6 ML; ALPROSTADIL/PAPAVERINE 10MCG/9MG/ML INJECTABLE; ALPROSTADIL/PHENT 10MCG/0.5MG/ML INJECTABLE 10 ML, 5 ML; ALPROSTADIL/PHENT 17MCG/0.5MG/ML INJECTABLE 10 ML; ALPROSTADIL/PHENTOLAMINE 40MCG/2MG/ML INJECTABLE 10 ML (50 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS)

by Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Reason
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 25, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

View recall →

Drug Recall Terminated Historical recordClass II

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.

by Nephron Pharmaceuticals Corp.

Reason
Lack of Assurance of Sterility
Recall initiated
June 22, 2011
Reported by FDA
August 15, 2012
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK

by Oklahoma Respiratory Care Inc

Reason
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Recall initiated
June 21, 2012
Reported by FDA
August 15, 2012
Distribution
OK

View recall →

Drug Recall Terminated Historical recordClass I

HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).

by Hospira Inc.

Reason
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Recall initiated
May 12, 2012
Reported by FDA
August 15, 2012
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.

by Apotex Corp.

Reason
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Recall initiated
April 5, 2012
Reported by FDA
August 15, 2012
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

by Teva Pharmaceuticals USA, Inc.

Reason
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Recall initiated
May 18, 2012
Reported by FDA
August 15, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,

by Axcentria Pharmaceuticals LLC

Reason
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Recall initiated
July 12, 2012
Reported by FDA
August 8, 2012
Distribution
Michigan

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Drug Recall Terminated Historical recordClass II

Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50

by VistaPharm, Inc.

Reason
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Recall initiated
September 30, 2011
Reported by FDA
August 8, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

by Apotex Inc.

Reason
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Recall initiated
April 30, 2012
Reported by FDA
August 8, 2012
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).

by West-Ward Pharmaceutical Corp.

Reason
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Recall initiated
April 13, 2012
Reported by FDA
August 8, 2012
Distribution
All lots were distributed throughout the US.

View recall →

Drug Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).

by West-Ward Pharmaceutical Corp.

Reason
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Recall initiated
April 13, 2012
Reported by FDA
August 8, 2012
Distribution
All lots were distributed throughout the US.

View recall →

Drug Recall Terminated Historical recordClass III

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

by Watson Laboratories Inc

Reason
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Recall initiated
June 5, 2012
Reported by FDA
August 8, 2012
Distribution
Nationwide.

View recall →

Data last updated:

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.