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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 12,041–12,060 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

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Drug Recall Terminated Historical recordClass I

PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.

by QuVa Pharma, Inc.

Reason
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Recall initiated
March 30, 2016
Reported by FDA
July 13, 2016
Distribution
CA

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Drug Recall Terminated Historical recordClass II

Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159

by Allergan Sales, LLC

Reason
Failed Content Uniformity Specifications.
Recall initiated
May 10, 2016
Reported by FDA
July 13, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612

by Allergan Sales, LLC

Reason
Failed Content Uniformity Specifications.
Recall initiated
May 10, 2016
Reported by FDA
July 13, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Recall initiated
June 3, 2016
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48

by Lyne Laboratories, Inc.

Reason
Subpotency: product assayed and found OOS for cyproheptadine
Recall initiated
June 7, 2016
Reported by FDA
July 13, 2016
Distribution
NJ

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Drug Recall Terminated Historical recordClass II

All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

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Drug Recall Terminated Historical recordClass III

Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

by Aidarex Pharmaceuticals LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Recall initiated
June 1, 2016
Reported by FDA
July 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

by Actavis Pharma Inc

Reason
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Recall initiated
March 16, 2016
Reported by FDA
July 6, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.

by Valeant Pharmaceuticals North America LLC

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Recall initiated
June 10, 2016
Reported by FDA
July 6, 2016
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass III

CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Recall initiated
April 22, 2016
Reported by FDA
July 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03

by KVK-Tech, Inc.

Reason
Discoloration: presence of scuffing marks on tablets.
Recall initiated
May 5, 2016
Reported by FDA
July 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS

by Vital Care Compounder

Reason
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Recall initiated
June 10, 2015
Reported by FDA
July 6, 2016
Distribution
MS

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Drug Recall Terminated Historical recordClass II

Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS

by Vital Care Compounder

Reason
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Recall initiated
June 10, 2015
Reported by FDA
July 6, 2016
Distribution
MS

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Drug Recall Terminated Historical recordClass II

Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS

by Vital Care Compounder

Reason
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Recall initiated
June 10, 2015
Reported by FDA
July 6, 2016
Distribution
MS

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Drug Recall Terminated Historical recordClass II

aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089

by The Aloe Source

Reason
CGMP Deviations
Recall initiated
May 11, 2016
Reported by FDA
July 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated
April 4, 2016
Reported by FDA
July 6, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.

by Prinston Pharmaceutical Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.
Recall initiated
May 30, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30

by Virtus Pharmaceuticals, Llc

Reason
Defective delivery system: Softgel capsules are leaking.
Recall initiated
May 16, 2016
Reported by FDA
June 29, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada

by Attix Pharmaceuticals Inc

Reason
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Recall initiated
May 18, 2016
Reported by FDA
June 29, 2016
Distribution
CO

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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.