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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 8,081–8,100 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

Reason
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Recall initiated
February 21, 2019
Reported by FDA
April 17, 2019
Distribution
Dispensed in Oregon

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Drug Recall Terminated Historical recordClass II

HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .

by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

Reason
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Recall initiated
February 21, 2019
Reported by FDA
April 17, 2019
Distribution
Dispensed in Oregon

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Drug Recall Terminated Historical recordClass II

ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

Reason
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Recall initiated
February 21, 2019
Reported by FDA
April 17, 2019
Distribution
Dispensed in Oregon

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Drug Recall Terminated Historical recordClass II

DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

Reason
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Recall initiated
February 21, 2019
Reported by FDA
April 17, 2019
Distribution
Dispensed in Oregon

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Drug Recall Terminated Historical recordClass II

SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

by Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy

Reason
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Recall initiated
February 21, 2019
Reported by FDA
April 17, 2019
Distribution
Dispensed in Oregon

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Drug Recall Terminated Historical recordClass III

Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.

by X-Gen Pharmaceuticals Inc.

Reason
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Recall initiated
March 29, 2019
Reported by FDA
April 17, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.

by H J Harkins Company Inc dba Pharma Pac

Reason
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Recall initiated
March 4, 2019
Reported by FDA
April 17, 2019
Distribution
Product was distributed to a physician's office in California.

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Drug Recall Terminated Historical recordClass III

Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.

by Auro Pharmacies Inc. DBA Central Drugs

Reason
Failed pH Specification: product does not meet pH label claim.
Recall initiated
March 22, 2019
Reported by FDA
April 17, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Losartan 50mg Tablet, 30 count each blister card.

by RemedyRePack Inc.

Reason
CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Recall initiated
March 14, 2019
Reported by FDA
April 17, 2019
Distribution
Product was distributed to one sole customer, Miami, FL.

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Drug Recall Terminated Historical recordClass III

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Recall initiated
March 28, 2019
Reported by FDA
April 10, 2019
Distribution
AR and MS

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Drug Recall Terminated Historical recordClass II

NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481

by KRS Global Biotechnology, Inc

Reason
Labeling: Label mix-up
Recall initiated
January 16, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343

by KRS Global Biotechnology, Inc

Reason
Labeling: Label mix-up
Recall initiated
January 16, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742

by Johnson Matthey Inc.

Reason
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Recall initiated
March 5, 2018
Reported by FDA
April 10, 2019
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

by Pacific Compounding Pharmacy & Consultations Inc

Reason
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Recall initiated
August 23, 2018
Reported by FDA
April 10, 2019
Distribution
California

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

by Legacy Pharmaceutical Packaging LLC

Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Recall initiated
March 1, 2019
Reported by FDA
April 10, 2019
Distribution
AZ, IN, TN

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Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Recall initiated
March 29, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02

by Pfizer Inc.

Reason
Presence of Particulate Matter; glass particulates
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
United States and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide USA and Guam

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Drug Recall Terminated Historical recordClass III

Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide USA and Guam

View recall →

Drug Recall Terminated Historical recordClass III

Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide USA and Guam

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.