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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 11,321–11,340 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90

by VIRTUS PHARMACEUTICALS OPCO II L

Reason
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Recall initiated
December 12, 2016
Reported by FDA
January 4, 2017
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass III

INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01

by Cipher Pharmaceuticals US LLC

Reason
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Recall initiated
December 6, 2016
Reported by FDA
January 4, 2017
Distribution
AZ, CO and OH.

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Drug Recall Terminated Historical recordClass II

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

by Sandoz Incorporated

Reason
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Recall initiated
December 22, 2016
Reported by FDA
January 4, 2017
Distribution
MS and OH.

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Drug Recall Terminated Historical recordClass III

Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139

by Care-Tech Laboratories, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Recall initiated
November 8, 2016
Reported by FDA
January 4, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639

by Raritan Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
November 18, 2016
Reported by FDA
January 4, 2017
Distribution
NY

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Drug Recall Terminated Historical recordClass II

Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639

by Raritan Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
November 18, 2016
Reported by FDA
January 4, 2017
Distribution
NY

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Drug Recall Terminated Historical recordClass II

CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162

by Raritan Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
November 18, 2016
Reported by FDA
January 4, 2017
Distribution
NY

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Drug Recall Terminated Historical recordClass II

COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.

by Sage Products LLC

Reason
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Recall initiated
July 29, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

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Drug Recall Terminated Historical recordClass I

Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502

by Town and Country Compounding and Consultation Services

Reason
Non-Sterility; microbial contamination identified as Bacillus circulans
Recall initiated
August 1, 2016
Reported by FDA
December 28, 2016
Distribution
MA, NY, NJ & FL; Canada

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Drug Recall Terminated Historical recordClass I

BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.

by Making It a Lifestyle

Reason
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Recall initiated
April 29, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR

by US Compounding Inc

Reason
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Recall initiated
July 25, 2016
Reported by FDA
December 28, 2016
Distribution
TX

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Drug Recall Ongoing Historical recordClass I

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

by Hospira Inc., A Pfizer Company

Reason
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Recall initiated
August 4, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.

by VIRTUS PHARMACEUTICALS OPCO II L

Reason
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Recall initiated
September 2, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.

by VIRTUS PHARMACEUTICALS OPCO II L

Reason
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Recall initiated
September 2, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

by Guardian Pharmacy Services

Reason
Non-Sterility: failed sterility test result.
Recall initiated
September 23, 2016
Reported by FDA
December 28, 2016
Distribution
Two medical facilities in TX

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Drug Recall Terminated Historical recordClass II

C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067

by Colonia Care Pharmacy

Reason
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Recall initiated
July 28, 2016
Reported by FDA
December 28, 2016
Distribution
NJ and NY

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Drug Recall Terminated Historical recordClass II

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Recall initiated
December 6, 2016
Reported by FDA
December 28, 2016
Distribution
United States, United Arab Emirates, and Colombia

View recall →

Drug Recall Terminated Historical recordClass II

2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.

by Sage Products LLC

Reason
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Recall initiated
July 29, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

View recall →

Drug Recall Terminated Historical recordClass I

COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.

by Sage Products LLC

Reason
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Recall initiated
July 29, 2016
Reported by FDA
December 28, 2016
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP

by Meta Pharmacy Services

Reason
Lack of Sterility Assurance
Recall initiated
December 15, 2016
Reported by FDA
December 28, 2016
Distribution
One consignee in Las Vegas

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.