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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 11,581–11,600 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of Assurance of Sterility
Recall initiated
July 26, 2016
Reported by FDA
October 5, 2016
Distribution
MS

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Drug Recall Terminated Historical recordClass III

PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91

by Pfizer Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Recall initiated
September 15, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10

by Mckesson Packaging Services

Reason
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Recall initiated
September 15, 2016
Reported by FDA
October 5, 2016
Distribution
CO, IL, LA, OH

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Drug Recall Terminated Historical recordClass II

Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-033-16.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.

by Pharmatech LLC

Reason
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Recall initiated
August 8, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.

by UNICHEM PHARMACEUTICALS USA INC

Reason
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Recall initiated
August 19, 2016
Reported by FDA
October 5, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01

by Genzyme Corporation / Genzyme Biosurgery

Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date
Recall initiated
August 4, 2016
Reported by FDA
September 28, 2016
Distribution
nationwide

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Drug Recall Terminated Historical recordClass III

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

by Reckitt Benckiser LLC

Reason
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Recall initiated
August 3, 2016
Reported by FDA
September 28, 2016
Distribution
FL, MA and NJ

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Drug Recall Terminated Historical recordClass III

Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01

by Lupin Limited

Reason
Labeling: Incorrect or Missing Lot and/or Expiration Date
Recall initiated
March 24, 2016
Reported by FDA
September 28, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

by West-Ward Pharmaceuticals Corp.

Reason
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Recall initiated
August 18, 2016
Reported by FDA
September 28, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Recall initiated
August 24, 2016
Reported by FDA
September 28, 2016
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.

by Sandoz Inc

Reason
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Recall initiated
August 24, 2016
Reported by FDA
September 28, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

by W & C dba The Apothecary

Reason
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Recall initiated
June 20, 2016
Reported by FDA
September 28, 2016
Distribution
MN

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Drug Recall Terminated Historical recordClass II

Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

by W & C dba The Apothecary

Reason
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Recall initiated
June 20, 2016
Reported by FDA
September 28, 2016
Distribution
MN

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

by W & C dba The Apothecary

Reason
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Recall initiated
June 20, 2016
Reported by FDA
September 28, 2016
Distribution
MN

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.