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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 17,741–17,760 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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Drug Recall Terminated Historical recordClass II

PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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Drug Recall Terminated Historical recordClass II

PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PHENTOLAMINE 5MG/ML INJECTABLE 20 ML 50 ML (5 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PANTOTHENIC ACID 1MG/ML INJECTABLE 30 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

PACLITAXEL 6MG/ML INJECTABLE 500 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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Drug Recall Terminated Historical recordClass II

OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE 100MG/ML INJECTABLE 5 ML; NANDROLONE DECANOATE 300MG/ML INJECTABLE 10 ML 30 ML (6 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 20MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 25MG/ML INTRATHECAL 20 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 38MG/ML INTRATHECAL 50 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 10MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE, P.F. 11.5MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 1MG/ML INJECTABLE 250 ML; MORPHINE SULFATE, P.F. 25MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 30MG/ML INTRATHECAL 18 ML; MORPHINE SULFATE, P.F. 33MG/ML INTRATHECAL 30 ML; MORPHINE SULFATE, P.F. 35MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 40MG/ML INTRATHECAL 18 ML 20 ML 35 ML; MORPHINE SULFATE, P.F. 42MG/ML INTRATHECAL 35 ML; MORPHINE SULFATE, P.F. 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. 5MG/ML INTRATHECAL 40 ML; MORPHINE SULFATE/BACLOFEN P.F. 25MG/1500MCG/ML INTRATHECAL 18 ML (28 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML 500 ML 6 ML 600 ML (9 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

View recall →

Drug Recall Terminated Historical recordClass II

METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML; METHYLPREDNISOLONE/LIDOCAINE 80MG/10MG/ML INJECTABLE 24 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated
May 21, 2012
Reported by FDA
August 22, 2012
Distribution
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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.