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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 8,141–8,160 of 17,964 drug recalls

Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54

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
March 27, 2019
Distribution
Wal-Mart distribution centers in AR, CA, GA, IN and MD

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Drug Recall Terminated Historical recordClass II

Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)

by American Health Packaging

Reason
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Recall initiated
March 6, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

by Camber Pharmaceuticals Inc

Reason
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recall initiated
February 28, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

by Camber Pharmaceuticals Inc

Reason
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recall initiated
February 28, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India

by Camber Pharmaceuticals Inc

Reason
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Recall initiated
February 28, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

by Advanced Pharma Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10

by Akorn Inc

Reason
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Recall initiated
March 12, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11

by Lupin Pharmaceuticals Inc.

Reason
Defective Container: Repetitive complaints received indicating pump not working.
Recall initiated
March 13, 2019
Reported by FDA
March 27, 2019
Distribution
Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.

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Drug Recall Terminated Historical recordClass II

Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.

by Iso-Tex Diagnostics, Inc

Reason
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Recall initiated
March 11, 2019
Reported by FDA
March 27, 2019
Distribution
TN

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Drug Recall Terminated Historical recordClass II

Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10

by Rx Pak Division of McKesson Corporation

Reason
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Recall initiated
January 16, 2019
Reported by FDA
March 27, 2019
Distribution
Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.

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Drug Recall Terminated Historical recordClass I

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30

by Mylan Institutional Inc

Reason
Presence of Particulate Matter: particulate matter identified as copper salts
Recall initiated
February 1, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide in the United States

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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.