Browse Drug Recalls
18,041 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,041 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 18,041 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/PGE-1 25 INJ**T 106** INJECTABLE, Rx on... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE,... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 1/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 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, T... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | IVME HCG VITAMIN B INJ (CONTAINS NO HCG) INJECTABLE, Rx only, Talon Compound... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 25MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Ta... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | (WELL'S LIPO-LEAN)INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+ CHROM+LIDO 25MG/25MG... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML IN OIL INJECTABLE, Rx only, ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Ta... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* INJECTABLE, Rx on... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/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 | QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 coun... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 40 /ML 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 2MG/ML IN OIL INJECTABLE, R... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pha... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/ML IN OIL INJECTABLE, Rx only... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 30/PHENTOLAMINE 0.5/PGE-1 10 INJ INJECTABLE, Rx only, Tal... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | HYDROXOCOBALAMIN 1,000MCG/ML INJ VIAL 1,000MCG/ML INJECTABLE, Rx only, Talon... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 30MG/ML #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 INJ INJECTABLE, Rx only, Talon Compound... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/DUTASTERIDE 1MG/ML IN OIL INJECTABLE... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME OIL INJECT... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | MEDROXYPROGESTERONE ACET 150MG/ML SUSP (PF) 150MG/ML SUSPENSION, Rx only, Ta... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/ML IN OIL INJECTAB... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 23.3/PHENTOLAMINE 1/PGE-1 12 INJ INJECTABLE, Rx only, Ta... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE,... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRI-MIX PAPAVERINE 40/PHENTOLAMINE 2/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 | TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 INJ INJECTABLE, Rx only, Ta... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding ... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 coun... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II | Lupin Pharmaceuticals Inc. |
| Oct 12, 2021 | QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 INJ INJECTABLE, Rx only, Ta... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TRIMTROPIC - MIC B COMPLEX/CHROM/CARN 20MG/40MG/50MG/5MG/33MG/2MG/1MG/25MCG/2... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | ALPROSTADIL 22.5MCG/ML 22.5MCG/ML INJECTABLE, Rx only, Talon Compounding Phar... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE,... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 12, 2021 | METHYLCOBALAMIN 1MG/ML (1000MCG/ML) INJ 1MG/ML INJECTABLE, Rx only, Talon Com... | Lack of assurance of sterility | Class II | Vita Pharmacy, LLC dba Talon Compounding Pharmacy |
| Oct 8, 2021 | Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo... | Out of specification result observed in a dissolution test at the 9-month long term stability tim... | Class II | Lupin Pharmaceuticals Inc. |
| Oct 5, 2021 | Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole... | CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within ... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottle... | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC ... | Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 5, 2021 | Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... | Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... | Class III | A-S Medication Solutions LLC. |
| Oct 4, 2021 | Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... | Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... | Class II | Akorn, Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, pa... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
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.