Public Health Trace

Get Alerts

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.

Filters

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 50MG/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 10MG/ML IN ETHYL OLEATE 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

CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG 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

BLUE TREE LIPO EXTREME (/W METHYLCOBALAMIN) INJECTION 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

B COMPLEX INJ CMP-NO B12, NO LIDOCAINE 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 40MCG/ML INJ 40MCG/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 22MCG/ML 22MCG/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

(WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE in vials, 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 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, 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 I

Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01

by MERCK SHARP & DOHME CORP

Reason: Presence of Particulate Matter: Identified as Glass Particles
Recall initiated: October 19, 2021
Reported by FDA: November 10, 2021
Distribution: Nationwide within the United States

View recall →

Drug Recall Completed Historical recordClass I

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Reason: Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Recall initiated: October 12, 2021
Reported by FDA: November 10, 2021
Distribution: Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recall initiated: October 12, 2021
Reported by FDA: November 10, 2021
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recall initiated: October 12, 2021
Reported by FDA: November 10, 2021
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recall initiated: October 12, 2021
Reported by FDA: November 10, 2021
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recall initiated: October 12, 2021
Reported by FDA: November 10, 2021
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

by Lupin Pharmaceuticals Inc.

Reason: CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Recall initiated: October 12, 2021
Reported by FDA: November 10, 2021
Distribution: Product was distributed to major distributors who may have further distributed the product nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05

by Dr. Reddy's Laboratories, 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 5, 2021
Reported by FDA: November 10, 2021
Distribution: Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall initiated: October 5, 2021
Reported by FDA: November 10, 2021
Distribution: Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall initiated: October 5, 2021
Reported by FDA: November 10, 2021
Distribution: Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Recall initiated: October 5, 2021
Reported by FDA: November 10, 2021
Distribution: Nationwide in the US

View recall →

Data last updated: September 13, 2026 ET

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.