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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 5,061–5,080 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01

by Eli Lilly & Company

Reason
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Recall initiated
June 29, 2021
Reported by FDA
August 18, 2021
Distribution
OH, MS, IN

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Drug Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05

by Aurobindo Pharma USA Inc.

Reason
Presence of Foreign Substance- Potential of metal contamination.
Recall initiated
July 7, 2021
Reported by FDA
August 18, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117

by People's Custom Rx and Clinical Care, LLC

Reason
Non-Sterility
Recall initiated
May 11, 2021
Reported by FDA
August 18, 2021
Distribution
MS, TN

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Drug Recall Terminated Historical recordClass I

HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.8MG/ML, l) 30MG-10MG/ML, m) 5MG-4MG/ML, n) 10MG/ML-20MG/ML, o) 40MG-5MG/ML, p) 20MG-20MG/ML, q) 30MG-20MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

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Drug Recall Terminated Historical recordClass I

HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605

by Med Shop Total Care Inc.

Reason
Non-Sterility
Recall initiated
October 5, 2020
Reported by FDA
August 18, 2021
Distribution
Texas and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Recall initiated
July 29, 2021
Reported by FDA
August 18, 2021
Distribution
Northstar Distribution Center 4853 Crumpler Rd. Memphis, TN 38141

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Drug Recall Ongoing Historical recordClass I

Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.

by Qikmoov LLC

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Recall initiated
July 14, 2021
Reported by FDA
August 11, 2021
Distribution
Distribution Nationwide in the USA via the internet and to the following countries Brazil, Canada, Germany, France, Hong Kong, Italy, Sweden, Switzerland, Thailand, and United Kingdom.

View recall →

Drug Recall Terminated Historical recordClass II

Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837

by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Reason
Lack of sterility assurance
Recall initiated
July 30, 2021
Reported by FDA
August 11, 2021
Distribution
FL

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.