Browse Drug Recalls

1,527 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,527 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 1,527 FDA drug recalls in FL.

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DateProductReasonClassFirm
Apr 4, 2022 SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atro... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . A... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Mul... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 1... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Mult... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atro... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropi... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharma... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 23, 2022 (CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Package... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dos... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable,... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, F... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 23, 2022 TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged ... Lack of sterility assurance. Class II Drug Depot, Inc., dba APS Pharmacy
Mar 8, 2022 NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... Product found to be Sub Potent or Exceeded reconstitution time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... Super Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 17... Super Potent and Failed Reconstitution Time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per... Sub Potent Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Feb 14, 2022 Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... Subpotent drug Class III BayCare Integrated Service Center, LLC /dba Bay...
Jan 10, 2022 Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)... CGMP Deviations Class II Ingenus Pharmaceuticals Llc
Jan 7, 2022 Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... Failed Stability Specifications Class II VistaPharm, Inc.
Dec 6, 2021 Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Sep 2, 2021 Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each... Subpotent Drug Class III New Vision Pharmaceuticals LLC
Sep 2, 2021 CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flav... Subpotent Drug Class III New Vision Pharmaceuticals LLC
Aug 24, 2021 Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laborator... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Dist... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, ... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Jul 30, 2021 Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg ... Failed Stability Specifications; out of specification for shear. Class II Noven Pharmaceuticals Inc
Jul 30, 2021 Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg ... Failed Stability Specifications; out of specification for shear. Class II Noven Pharmaceuticals Inc
Jul 30, 2021 Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For ... Lack of sterility assurance Class II BayCare Integrated Service Center, LLC /dba Bay...
Jun 30, 2021 MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50... Lack of processing controls Class II Promise Pharmacy, LLC
May 21, 2021 DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx ... Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. Class II Hill Dermaceuticals, 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.