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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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Drug Recall Terminated Historical recordClass II

Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.

by Par Sterile Products LLC

Reason: Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Recall initiated: April 28, 2017
Reported by FDA: May 17, 2017
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02

by Akorn, Inc.

Reason: Product is being recalled due to low pH value.
Recall initiated: April 20, 2017
Reported by FDA: May 17, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16

by Akorn Inc

Reason: Failed Dissolution Specifications
Recall initiated: March 13, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

by Fagron, Inc

Reason: Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Recall initiated: April 17, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide within US

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Drug Recall Terminated Historical recordClass III

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.

by P & L Development, LLC

Reason: Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Recall initiated: April 17, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

by Amneal Pharmaceuticals LLC

Reason: Failed Dissolution Specifications
Recall initiated: December 12, 2016
Reported by FDA: May 10, 2017
Distribution: Nationwide within the US and PR

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Drug Recall Terminated Historical recordClass III

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

by The Harvard Drug Group

Reason: Superpotent Drug; out of specification results for assay (manufacturer)
Recall initiated: December 27, 2016
Reported by FDA: May 10, 2017
Distribution: Nationwide and PR

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Drug Recall Ongoing Historical recordClass I

EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

by Meridian Medical Technologies a Pfizer Company

Reason: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Recall initiated: March 12, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.

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Drug Recall Ongoing Historical recordClass I

EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.

by Meridian Medical Technologies a Pfizer Company

Reason: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Recall initiated: March 12, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.

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Drug Recall Terminated Historical recordClass II

Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61

by The Harvard Drug Group

Reason: Failed Dissolution Specifications
Recall initiated: January 5, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide within the US

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Drug Recall Terminated Historical recordClass II

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61

by The Harvard Drug Group

Reason: Failed Dissolution Specifications
Recall initiated: January 5, 2017
Reported by FDA: May 10, 2017
Distribution: Nationwide within the US

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Drug Recall Terminated Historical recordClass II

Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.

by Isomeric Pharmacy Solution, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: April 6, 2017
Reported by FDA: May 3, 2017
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10

by Mckesson Packaging Services

Reason: Supotent: Out of Specification result for assay test during routine stability testing.
Recall initiated: January 4, 2017
Reported by FDA: May 3, 2017
Distribution: CO, LA and OH.

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Drug Recall Terminated Historical recordClass III

Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

by Novartis Pharmaceuticals Corp.

Reason: Failed Impurities/Degradation Specifications.
Recall initiated: March 22, 2017
Reported by FDA: May 3, 2017
Distribution: nationwide

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Data last updated: September 24, 2026 ET

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.