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.

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DateProductReasonClassFirm
Dec 17, 2014 Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor,... Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate ... Class II Tropichem Research Labs, Inc.
Dec 12, 2014 ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Dec 12, 2014 M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietioc... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Dec 12, 2014 7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), C... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Dec 12, 2014 PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,1... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Dec 12, 2014 M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Dec 12, 2014 SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Dec 12, 2014 HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol ... Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of... Class I Anabolic Science Labs, LLC
Sep 26, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Presence of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Sep 12, 2014 Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, R... Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled roo... Class II Mckesson
Aug 21, 2014 Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count... Failed Impurity/Degradation Specification; high out of specification for CAD II degradant Class III Apotex Corp.
Aug 13, 2014 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), ... Defective Container: Product leaks when inverted. Class II VistaPharm, Inc.
Jul 15, 2014 Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... Class II Noven Pharmaceuticals, Inc.
May 15, 2014 Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th St... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Stre... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C S... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 18, 2014 Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. Class III Apotex Corp.
Apr 17, 2014 Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trig... Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 mic... Class III Trigen Laboratories, Inc.
Apr 10, 2014 Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Apr 10, 2014 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube p... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Feb 13, 2014 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho... Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which re... Class II Noven 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.