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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 13,781–13,800 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Morphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Cefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl in Dextrose, VANCOMYCIN 750mg / D5W 150mL, Qty: 12 150 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Fluorouracil 1200mg / D5W 274mL, Qty: 1 274 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Fluorouracil 1400mg / D5W 278mL Qty: 1 278 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.

by Lincare, Inc.

Reason
Lack of Assurance of Sterility: Sterility of product is not assured.
Recall initiated
May 28, 2015
Reported by FDA
July 8, 2015
Distribution
United States including: Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61.

by The Harvard Drug Group, LLC

Reason
Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
Recall initiated
June 10, 2015
Reported by FDA
July 8, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342

by Indiana Botanic Gardens, Inc

Reason
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Recall initiated
June 4, 2015
Reported by FDA
July 1, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28

by Actavis Inc

Reason
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Recall initiated
June 4, 2015
Reported by FDA
July 1, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01

by Bracco Diagnostic Inc

Reason
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Recall initiated
May 27, 2015
Reported by FDA
July 1, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count bottle (NDC 43598-316-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent drug
Recall initiated
May 6, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India, NDC 43598-315-90

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent drug
Recall initiated
May 6, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent drug
Recall initiated
May 6, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent drug
Recall initiated
May 6, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 200 Wilmot Rd, Deerfield, IL 60015, UPC 311917155623 (Walgreens brand)

by Ohm Laboratories, Inc.

Reason
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Recall initiated
May 4, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.

by AstraZeneca Pharmaceuticals LP

Reason
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Recall initiated
June 10, 2015
Reported by FDA
June 24, 2015
Distribution
Nationwide to wholesalers for further distribution at the retail level.

View recall →

Drug Recall Terminated Historical recordClass II

Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11

by American Health Packaging

Reason
Failed dissolution specifications
Recall initiated
March 2, 2015
Reported by FDA
June 24, 2015
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.