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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 11,641–11,660 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

by Akorn, Inc.

Reason
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Recall initiated
July 27, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Recall initiated
September 17, 2013
Reported by FDA
August 31, 2016
Distribution
Nationwide, Puerto Rico and Guam

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Recall initiated
September 17, 2013
Reported by FDA
August 31, 2016
Distribution
Nationwide, Puerto Rico and Guam

View recall →

Drug Recall Terminated Historical recordClass II

Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Reason
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Recall initiated
September 17, 2013
Reported by FDA
August 31, 2016
Distribution
Nationwide, Puerto Rico and Guam

View recall →

Drug Recall Terminated Historical recordClass III

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY

by Exact-Rx Inc

Reason
Crystallization; complaints received by the manufacturer of crystals forming in product
Recall initiated
June 2, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide

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Drug Recall Completed Historical recordClass III

Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.

by Stratus Pharmaceuticals Inc

Reason
Crystallization; Complaints that cream appears to have crystallized
Recall initiated
May 26, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide and PR

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Drug Recall Terminated Historical recordClass II

Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247

by Talon Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
July 19, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247

by Talon Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
July 19, 2016
Reported by FDA
August 31, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.

by Zydus Pharmaceuticals USA Inc

Reason
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Recall initiated
July 19, 2016
Reported by FDA
August 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.

by Zydus Pharmaceuticals USA Inc

Reason
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Recall initiated
July 19, 2016
Reported by FDA
August 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90

by Golden State Medical Supply Inc.

Reason
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Recall initiated
August 3, 2016
Reported by FDA
August 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.

by Golden State Medical Supply Inc.

Reason
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Recall initiated
August 3, 2016
Reported by FDA
August 24, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30

by Actavis Inc

Reason
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Recall initiated
June 30, 2016
Reported by FDA
August 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901

by Spectrum Laboratory Products, Inc.

Reason
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Recall initiated
August 1, 2016
Reported by FDA
August 17, 2016
Distribution
US: MA, TN, GA, MO and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16

by Teva North America

Reason
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Recall initiated
June 22, 2016
Reported by FDA
August 17, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109

by Isomeric Pharmacy Solution, LLC

Reason
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Recall initiated
August 1, 2016
Reported by FDA
August 10, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324; NDC 59310-206-08.

by Teva North America

Reason
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Recall initiated
July 15, 2016
Reported by FDA
August 10, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.

by Let's Talk Health, Inc.

Reason
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Recall initiated
July 5, 2016
Reported by FDA
August 10, 2016
Distribution
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines

View recall →

Drug Recall Terminated Historical recordClass III

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

by Teva North America

Reason
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Recall initiated
May 31, 2016
Reported by FDA
August 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69

by Sagent Pharmaceuticals Inc

Reason
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Recall initiated
June 13, 2016
Reported by FDA
August 3, 2016
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.