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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 14,661–14,680 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

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Drug Recall Terminated Historical recordClass II

HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7906-71

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5230-12

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44

by Perry Drug Inc.

Reason
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated
November 7, 2014
Reported by FDA
December 3, 2014
Distribution
Kansas and Missouri

View recall →

Drug Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.

by Actavis Laboratories, FL, Inc.

Reason
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Recall initiated
September 26, 2014
Reported by FDA
December 3, 2014
Distribution
U.S. Nationwide including Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16

by Zydus Pharmaceuticals USA Inc

Reason
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Recall initiated
October 1, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

by Baxter Healthcare Corp.

Reason
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Recall initiated
November 10, 2014
Reported by FDA
December 3, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.

by Spectrum Laboratory Products

Reason
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Recall initiated
July 18, 2014
Reported by FDA
November 26, 2014
Distribution
U.S.: California.

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Drug Recall Terminated Historical recordClass III

Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01.

by Hospira Inc.

Reason
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Recall initiated
November 7, 2014
Reported by FDA
November 26, 2014
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10

by Micro Labs Usa, Inc S

Reason
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Recall initiated
September 22, 2014
Reported by FDA
November 26, 2014
Distribution
U.S. Including: New York

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Drug Recall Terminated Historical recordClass I

Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

by Abrams Royal Pharmacy

Reason
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Recall initiated
May 13, 2013
Reported by FDA
November 26, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

by Abrams Royal Pharmacy

Reason
Non-Sterility
Recall initiated
April 19, 2013
Reported by FDA
November 26, 2014
Distribution
Texas

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Drug Recall Terminated Historical recordClass I

Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.

by Abrams Royal Pharmacy

Reason
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Recall initiated
May 31, 2013
Reported by FDA
November 26, 2014
Distribution
Two hospitals in Dallas, TX

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Drug Recall Terminated Historical recordClass II

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

by Prometheus Laboratories Inc.

Reason
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Recall initiated
October 22, 2014
Reported by FDA
November 26, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320

by Contract Packaging Resources Inc.

Reason
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Recall initiated
October 10, 2014
Reported by FDA
November 19, 2014
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.