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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 12,301–12,320 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

by Meditech Laboratories, Inc

Reason
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Recall initiated
March 14, 2016
Reported by FDA
April 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

by Meditech Laboratories, Inc

Reason
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Recall initiated
March 14, 2016
Reported by FDA
April 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

by Meditech Laboratories, Inc

Reason
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Recall initiated
March 14, 2016
Reported by FDA
April 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .

by Meditech Laboratories, Inc

Reason
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Recall initiated
March 14, 2016
Reported by FDA
April 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.

by Meditech Laboratories, Inc

Reason
Superpotent Drug: one ingredient was found to be above assay specification.
Recall initiated
March 14, 2016
Reported by FDA
April 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305

by Virtus Pharmaceuticals, Llc

Reason
Defective Delivery System: Product may contain leaking capsules.
Recall initiated
December 17, 2015
Reported by FDA
April 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18

by PFIZER INC

Reason
Labeling: Label Mix-Up
Recall initiated
February 10, 2016
Reported by FDA
April 6, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

by Genzyme Corporation

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
December 8, 2015
Reported by FDA
April 6, 2016
Distribution
TN

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Drug Recall Terminated Historical recordClass II

Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

View recall →

Drug Recall Terminated Historical recordClass II

Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47

by Walter's Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
February 12, 2016
Reported by FDA
April 6, 2016
Distribution
PA

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.