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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 14,521–14,540 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540

by Micro Labs Usa, Inc S

Reason
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Recall initiated
December 4, 2014
Reported by FDA
March 18, 2015
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15

by Actavis Inc

Reason
Subpotent Drug
Recall initiated
February 12, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.

by Akorn, Inc.

Reason
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Recall initiated
February 27, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
February 26, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
February 26, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15

by AVKARE Inc.

Reason
Subpotent Drug
Recall initiated
February 27, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15

by AVKARE Inc.

Reason
Subpotent Drug
Recall initiated
February 27, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic liners in a single fiber carton, For manufacturing, processing, or repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446. NDC 10117-3004

by Nanophase Technologies Corporation

Reason
Labeling: Illegible label. Writing is rubbing off of labels.
Recall initiated
February 12, 2015
Reported by FDA
March 11, 2015
Distribution
NJ

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Drug Recall Terminated Historical recordClass II

Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10

by Sagent Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Recall initiated
February 23, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05

by Sagent Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Recall initiated
February 23, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

by Qualitest Pharmaceuticals

Reason
Failed tablet specifications: One lot was found to contain oversized tablets.
Recall initiated
February 13, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15

by Actavis Inc

Reason
Subpotent Drug
Recall initiated
February 12, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.

by Actavis Elizabeth LLC

Reason
Failed Dissolution Specifications
Recall initiated
February 10, 2015
Reported by FDA
March 11, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.

by Sun Pharma Global Fze

Reason
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Recall initiated
January 21, 2015
Reported by FDA
March 4, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)

by Par Pharmaceutical Inc.

Reason
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Recall initiated
February 12, 2015
Reported by FDA
March 4, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09

by Hospira Inc.

Reason
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Recall initiated
July 10, 2014
Reported by FDA
February 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045

by Hospira Inc.

Reason
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Recall initiated
October 16, 2014
Reported by FDA
February 25, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall initiated
October 6, 2014
Reported by FDA
February 25, 2015
Distribution
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.

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Drug Recall Terminated Historical recordClass I

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall initiated
October 6, 2014
Reported by FDA
February 25, 2015
Distribution
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.

View recall →

Drug Recall Terminated Historical recordClass II

Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.

by Hospira Inc.

Reason
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall initiated
October 6, 2014
Reported by FDA
February 25, 2015
Distribution
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.

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.