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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 12,441–12,460 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8.

by Alcon Research, Ltd.

Reason
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
Recall initiated
February 9, 2016
Reported by FDA
February 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15

by Bonita Pharmaceuticals, LLC

Reason
Marketed without an approved NDA/ANDA
Recall initiated
January 27, 2016
Reported by FDA
February 24, 2016
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass I

Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida

by Life and More LLC

Reason
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Recall initiated
July 13, 2015
Reported by FDA
February 24, 2016
Distribution
Nationwide and Colombia, South America

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Drug Recall Terminated Historical recordClass I

ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.

by Medline Industries Inc

Reason
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Recall initiated
September 25, 2015
Reported by FDA
February 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.

by Medline Industries Inc

Reason
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Recall initiated
September 25, 2015
Reported by FDA
February 24, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.

by Safecor Health, LLC

Reason
Defective Container: Confirmed customer complaints of leaking bottles.
Recall initiated
March 2, 2015
Reported by FDA
February 17, 2016
Distribution
NJ

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Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

by Amerisource Health Services

Reason
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Recall initiated
January 26, 2016
Reported by FDA
February 17, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

by Sandoz Inc

Reason
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Recall initiated
December 31, 2015
Reported by FDA
February 17, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.

by PharMEDium Services, LLC

Reason
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Recall initiated
May 22, 2015
Reported by FDA
February 17, 2016
Distribution
WI

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Drug Recall Terminated Historical recordClass II

Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.

by Safecor Health, LLC

Reason
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Recall initiated
August 13, 2015
Reported by FDA
February 17, 2016
Distribution
NY

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Drug Recall Terminated Historical recordClass II

SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Recall initiated
November 11, 2015
Reported by FDA
February 17, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Recall initiated
November 11, 2015
Reported by FDA
February 17, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.

by Fagron, Inc

Reason
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Recall initiated
November 11, 2015
Reported by FDA
February 17, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.

by Macleods Pharma Usa Inc

Reason
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Recall initiated
December 24, 2015
Reported by FDA
February 17, 2016
Distribution
US Nationwide.

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Drug Recall Terminated Historical recordClass II

Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157

by Perrigo Company PLC

Reason
Labeling: label error on declared strength.
Recall initiated
January 18, 2016
Reported by FDA
February 10, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

by Perrigo Company PLC

Reason
Labeling: label error on declared strength.
Recall initiated
January 18, 2016
Reported by FDA
February 10, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21

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

Reason
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Recall initiated
January 28, 2016
Reported by FDA
February 10, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68

by Pfizer Inc.

Reason
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Recall initiated
January 11, 2016
Reported by FDA
February 10, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68

by Pfizer Inc.

Reason
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Recall initiated
January 11, 2016
Reported by FDA
February 10, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

by Bausch & Lomb, Inc.

Reason
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Recall initiated
January 18, 2016
Reported by FDA
February 3, 2016
Distribution
U.S. Nationwide including Puerto Rico.

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.