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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 12,241–12,260 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.

by Fresenius Kabi USA, LLC

Reason
Failed Impuities/Degradation Specifications
Recall initiated
May 4, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico.

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Drug Recall Ongoing Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

by Hospira Inc.

Reason
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Recall initiated
March 18, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: identified as dried skin.
Recall initiated
January 21, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: identified as a cloth fiber.
Recall initiated
January 21, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: identified as cardboard.
Recall initiated
January 21, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

by Baxter Healthcare Corp.

Reason
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Recall initiated
January 21, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass I

LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com

by Lipo Escultura Corp.

Reason
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Recall initiated
December 3, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide via Internet sales

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Drug Recall Terminated Historical recordClass I

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03

by Teva Pharmaceuticals USA

Reason
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Recall initiated
March 9, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30

by Lymol Medical

Reason
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Recall initiated
April 28, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.

by Pfizer Inc.

Reason
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Recall initiated
April 28, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

by Allegiant Health

Reason
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Recall initiated
February 29, 2016
Reported by FDA
May 25, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03

by TMIG Inc

Reason
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Recall initiated
March 23, 2016
Reported by FDA
May 25, 2016
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass III

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

by Hospira Inc.

Reason
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Recall initiated
March 23, 2016
Reported by FDA
May 25, 2016
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago

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Drug Recall Terminated Historical recordClass II

BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.

by Keystone Laboratories Inc

Reason
Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
Recall initiated
April 4, 2016
Reported by FDA
May 25, 2016
Distribution
U.S. Including: MD and NJ

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Drug Recall Terminated Historical recordClass II

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87

by Baxter Healthcare Corp.

Reason
Discoloration: presence of atypical yellow discoloration of the solution .
Recall initiated
April 12, 2016
Reported by FDA
May 18, 2016
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Ongoing Historical recordClass II

Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Ongoing Historical recordClass II

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

View recall →

Drug Recall Ongoing Historical recordClass II

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

View recall →

Drug Recall Ongoing Historical recordClass II

Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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.