Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
Oct 12, 2021 TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/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 L-CARNITINE 250MG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 29... 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 PAPAV 23.3MG/PHENTOL 1MG/PGE-1 12MCG/ML INJ INJECTABLE, Rx only, Ta... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same... Class II Teligent Pharma, Inc.
Oct 12, 2021 ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL 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 3/PGE-1 100/ATROPINE 0.2 INJ INJECTABLE, Rx only... 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 50 INJ INJECTABLE, Rx only, Talo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.75MG/ML IN OIL INJECTABLE, Rx onl... 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 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx on... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon C... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 17.65/PHENTOLAMINE 0.59/PGE-1 5.9 INJ **T 101** INJECTABL... 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 #2 INJECTABLE, Rx ... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ INJECTABLE, Rx only, ... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 PROGESTERONE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compo... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ INJECTABLE, Rx only, ... 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... Failed Moisture Limits Class III SUN PHARMACEUTICAL INDUSTRIES INC
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 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 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 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 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 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 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 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 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 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 (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 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 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

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.