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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 13,961–13,980 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.

by Detox Transforms

Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Recall initiated
January 25, 2015
Reported by FDA
May 13, 2015
Distribution
WV who distributed Nationwide.

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Drug Recall Terminated Historical recordClass I

EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.

by Detox Transforms

Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Recall initiated
January 25, 2015
Reported by FDA
May 13, 2015
Distribution
WV who distributed Nationwide.

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Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.

by Hospira Inc.

Reason
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Recall initiated
March 5, 2015
Reported by FDA
May 13, 2015
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA

by Wockhardt Usa Inc.

Reason
Failed Tablet/Capsule Specifications: out of specification for thickness.
Recall initiated
March 12, 2015
Reported by FDA
May 13, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01

by RemedyRePack Inc.

Reason
Crystallization
Recall initiated
April 23, 2015
Reported by FDA
May 13, 2015
Distribution
PA and OK

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Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49

by Hospira Inc.

Reason
Crystallization
Recall initiated
April 13, 2015
Reported by FDA
May 6, 2015
Distribution
Nationwide, Puerto Rico and Guam.

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Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49

by Hospira Inc.

Reason
Crystallization
Recall initiated
April 13, 2015
Reported by FDA
May 6, 2015
Distribution
Nationwide, Puerto Rico and Guam.

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Drug Recall Terminated Historical recordClass II

Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960

by Teva Pharmaceuticals USA

Reason
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Recall initiated
April 13, 2015
Reported by FDA
May 6, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01

by Teva Pharmaceuticals USA

Reason
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Recall initiated
April 13, 2015
Reported by FDA
May 6, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)

by Tarmac Products, Inc.

Reason
Products failed the Antimicrobial Effectiveness Test
Recall initiated
April 16, 2015
Reported by FDA
April 29, 2015
Distribution
Nationwide to 13 Walgreen Distribution Centers and Pharmacies.

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Drug Recall Terminated Historical recordClass II

Zolmitriptan active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

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Drug Recall Terminated Historical recordClass II

Zidovudine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

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Drug Recall Terminated Historical recordClass II

Vardenafil HCl Trihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

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Drug Recall Terminated Historical recordClass II

Vancomycin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

View recall →

Drug Recall Terminated Historical recordClass II

Trehalose Dihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

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Drug Recall Terminated Historical recordClass II

Tramadol HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

View recall →

Drug Recall Terminated Historical recordClass II

Tobramycin Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

View recall →

Drug Recall Terminated Historical recordClass II

Thyroid Porcine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

View recall →

Drug Recall Terminated Historical recordClass II

Thiotepa active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

View recall →

Drug Recall Terminated Historical recordClass II

Thimerosal active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada

by Attix Pharmaceuticals

Reason
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Recall initiated
November 14, 2014
Reported by FDA
April 29, 2015
Distribution
Nationwide to compounding pharmacies and research organizations.

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.