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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Date	Product	Reason	Class	Firm
Jan 30, 2013	AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor,...	CGMP Deviations: Products are underdosed or have an incorrect dosage regime.	Class II	TG United, Inc.
Nov 21, 2012	Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx o...	Subpotent; 12 month stability timepoint	Class III	Hill Dermaceuticals, Inc.
Nov 21, 2012	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx on...	Subpotent; 22 month stability timepoint	Class III	Hill Dermaceuticals, Inc.
Sep 20, 2012	SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Pr...	Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppr...	Class I	Globe All Wellness, LLC
Sep 17, 2012	UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective ag...	Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count ab...	Class II	DermaCare, Inc.
Sep 17, 2012	UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective ag...	Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count ab...	Class II	DermaCare, Inc.
Jul 16, 2012	X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 1...	Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil...	Class I	Coral Rock Man, Inc.
Jul 16, 2012	Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792...	Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sil...	Class I	Coral Rock Man, Inc.
Jul 12, 2012	Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
Jul 12, 2012	Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
Jul 12, 2012	Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 ho...	Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel ...	Class II	Noven Pharmaceuticals, Inc.
May 30, 2012	Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL,...	Impurities/Degradation Products: exceeded specification at 3 month stability testing	Class II	VistaPharm, Inc.
May 25, 2012	FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONI...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABL...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIU...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 50...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PROD...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALM...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML I...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECA...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 5...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOL...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTAB...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	FUROSEMIDE* (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE* (25X4ML) 10M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHAL...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN P...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 M...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012	DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJE...	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d...	Class II	Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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.