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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 4,721–4,740 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

IVME SUPER B INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 45MCG/ML 45MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3

by A-S Medication Solutions LLC.

Reason
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Recall initiated
October 5, 2021
Reported by FDA
November 17, 2021
Distribution
FL, IN, MN, WI

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

by Precision Dose Inc.

Reason
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Recall initiated
November 1, 2021
Reported by FDA
November 17, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

by Precision Dose Inc.

Reason
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Recall initiated
November 1, 2021
Reported by FDA
November 17, 2021
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50

by Ascend Laboratories LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
November 3, 2021
Reported by FDA
November 17, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05

by Golden State Medical Supply Inc.

Reason
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Recall initiated
October 14, 2021
Reported by FDA
November 17, 2021
Distribution
Distributed to two distributors located in AZ and MO

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/PGE-1 40 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 7.5/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

by Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Reason
Lack of assurance of sterility
Recall initiated
October 12, 2021
Reported by FDA
November 17, 2021
Distribution
United States including Washington, D.C. and Puerto Rico

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.