Browse Drug Recalls
1,528 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,528 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 1,528 FDA drug recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2018 | QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube,... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slipper... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 2, 2018 | Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale B... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale ... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Halla... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale B... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Be... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Aug 2, 2018 | Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandal... | Lack of assurance of sterility. | Class II | Pharmcore Inc. |
| Jun 8, 2018 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Sing... | Superpotent Drug: High out of specification assay value results for potency. | Class II | Ingenus Pharmaceuticals Llc |
| Jun 8, 2018 | Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Sin... | Superpotent Drug: High out of specification assay value results for potency. | Class II | Ingenus Pharmaceuticals Llc |
| May 17, 2018 | POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-cou... | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... | Class I | Shoreside Enterprises Inc. |
| May 17, 2018 | 7K capsules packaged in single packs sold in 24-count boxes, Distributed by S... | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... | Class I | Shoreside Enterprises Inc. |
| May 4, 2018 | Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (N... | Defective Delivery System: no longer meets the specification for shear, an attribute related to t... | Class II | Noven Pharmaceuticals, Inc. |
| May 4, 2018 | Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC ... | Defective Delivery System: no longer meets the specification for shear, an attribute related to t... | Class II | Noven Pharmaceuticals, Inc. |
| Apr 26, 2018 | Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggrega... | Lack of Assurance of Sterility | Class II | Coast Quality Pharmacy LLC |
| Apr 11, 2018 | Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 11, 2018 | Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 11, 2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 11, 2018 | NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 9, 2018 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... | Defective Delivery System: Out of specification for adhesive transfer. | Class II | Noven Pharmaceuticals, Inc. |
| Mar 28, 2018 | Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, M... | cGMP Deviations | Class II | Elroselabs Inc. |
| Mar 28, 2018 | Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. | cGMP Deviations | Class II | Elroselabs Inc. |
| Mar 28, 2018 | Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), El... | cGMP Deviations | Class II | Elroselabs Inc. |
| Feb 7, 2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... | CGMP Deviations: not manufactured according to current good manufacturing practices. | Class III | Webrx dba RxPalace.com |
| Jan 24, 2018 | Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g... | Superpotent drug: failed assay throughout the stick after 6 months stability. | Class III | Oxygen Development Llc |
| Jan 12, 2018 | Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30... | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... | Class II | International Laboratories, Inc. |
| Jan 12, 2018 | Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30... | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... | Class II | International Laboratories, Inc. |
| Jan 11, 2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde... | Labeling: Label Error on Declared Strength | Class II | Premier Pharmacy Labs Inc |
| Jan 4, 2018 | Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... | LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... | Class I | International Laboratories, LLC |
| Nov 30, 2017 | Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Te... | Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil | Class III | BYL Solutions Inc. |
| Nov 16, 2017 | Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Bi... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechno... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Globa... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx On... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, R... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global B... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mes... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx O... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Onl... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only,... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Comm... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, Inc |
| Nov 16, 2017 | Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology,... | Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... | Class II | KRS Global Biotechnology, 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.