Browse Drug Recalls
972 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 972 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 972 FDA drug recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 18, 2023 | Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla ... | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... | Class II | Integrity Bio-Chemicals LLC |
| Aug 25, 2023 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1... | Class II | CareFusion 213, LLC |
| Aug 14, 2023 | All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by In... | CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Al... | Class II | Inmar Supply Chain Solutions, LLC |
| May 12, 2023 | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple... | Mislabeling: preservative free product labeled as preserved. | Class II | Empower Clinic Services LLC dba Empower Pharmacy |
| May 11, 2023 | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use O... | Sub-potent Drug | Class II | Revive Rx LLC dba Revive Rx Pharmacy |
| Apr 19, 2023 | Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Sol... | Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the label... | Class II | Seatex LLC |
| Apr 6, 2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 m... | CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. | Class II | Pharma Nobis LLC |
| Dec 9, 2022 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,... | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o... | Class II | NCH Life Sciences LLC |
| Sep 9, 2022 | Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: ... | Marketed Without An Approved NDA/ANDA; Unapproved new drug | Class II | Justified Laboratories |
| Sep 9, 2022 | Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: ... | Marketed Without An Approved NDA/ANDA; Unapproved new drug | Class II | Justified Laboratories |
| Apr 14, 2022 | Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content | Class III | Monarch PCM, LLC |
| Apr 5, 2022 | LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenv... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Green... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio ... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, F... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 5, 2022 | PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only,... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | North American Custom Laboratories, LLC dba Far... |
| Apr 1, 2022 | CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered... | Marketed Without an Approved NDA/ANDA | Class II | Wellness BioSciences |
| Feb 11, 2022 | HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only... | Non-sterility; bacterial contamination identified as Paenibacillus lautus. | Class I | Revive Rx LLC dba Revive Rx Pharmacy |
| Nov 17, 2021 | Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, F... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 17, 2021 | Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, Fo... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 17, 2021 | Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, Fo... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 30 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmac... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Ph... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmac... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pha... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | METHYLCOBALAMIN 5MG/ML (5000MCG/ML) INJ 5MG/ML INJECTABLE, Rx only, Talon Co... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 INJ INJECTABLE, Rx only, Tal... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, R... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 15/PHENTOLAMINE 2/PGE-1 20 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE,... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Co... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 20 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 15/PHENTOLAMINE 1/PGE-1 10 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | MIC 20/40/50 /B COMPLEX +CHROM/CARN 25/25MG/ML 20/40/50/25/25MG/ML INJECTABLE... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 4/PGE-1 60 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talo... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 2/PGE-1 20 INJ **T 104** INJECTABLE, Rx o... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML INJ INJECTABLE, Rx only, Talon C... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ALPROSTADIL 45MCG/ML 45MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmac... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, R... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE, Rx only, Talon Co... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | LEUCINE 10MG/ ISOLEUCINE 15MG/ VALINE 40MG/ML (BCAA) INJ 10MG/15MG/40MG/ML IN... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 30 INJ INJECTABLE, Rx only, Tal... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME OIL INJECTABLE, ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.