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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 13,861–13,880 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

by Apotex Inc.

Reason
Subpotent drug
Recall initiated
April 7, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.

by Cipla Limited

Reason
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Recall initiated
April 24, 2015
Reported by FDA
May 20, 2015
Distribution
U.S. Nationwide including Puerto Rico.

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Drug Recall Terminated Historical recordClass III

MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30

by Medtech Products, Inc.

Reason
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Recall initiated
April 10, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

by Hospira Inc.

Reason
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Recall initiated
March 6, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

by Fallon Wellness Pharmacy, L.L.C.

Reason
Lack of assurance of sterility
Recall initiated
March 17, 2015
Reported by FDA
May 20, 2015
Distribution
New York

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Drug Recall Terminated Historical recordClass II

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23

by Mission Pharmacal Co

Reason
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Recall initiated
April 30, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23

by Mission Pharmacal Co

Reason
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Recall initiated
April 30, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

by Janssen Pharmaceuticals, Inc.

Reason
Subpotent Drug
Recall initiated
April 29, 2015
Reported by FDA
May 20, 2015
Distribution
Nationwide and Canada

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Drug Recall Terminated Historical recordClass II

Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

by Health Innovations Pharmacy, Inc

Reason
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Recall initiated
February 12, 2015
Reported by FDA
May 20, 2015
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

by Health Innovations Pharmacy, Inc

Reason
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Recall initiated
February 12, 2015
Reported by FDA
May 20, 2015
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

by Health Innovations Pharmacy, Inc

Reason
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Recall initiated
February 12, 2015
Reported by FDA
May 20, 2015
Distribution
NC

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.