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Browse Drug Recalls

534 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 534 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 534 FDA drug recalls in 2012.

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DateProductReasonClassFirm
Jun 5, 2012 Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... Impurities/Degradation Products: High Out-of-specification results were obtained for both known a... Class III Watson Laboratories Inc
Jun 4, 2012 Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 6... Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrec... Class II GlaxoSmithKline Inc
Jun 1, 2012 CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution... GMP deviation; Sr-82 levels exceeded alert limit specification Class II Bracco Diagnostics Inc
May 31, 2012 Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, ... Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin... Class III Bayer HealthCare 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 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone ... Class III Mallinckrodt Inc.
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
May 25, 2012 ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 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 GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15... 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 GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAM... 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 V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 280... Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafi... Class I The Menz Club, LLC
May 25, 2012 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 ... CGMP Deviations: This product is being recalled because expired flavoring was used in the manufac... Class II Mallinckrodt Inc.
May 25, 2012 EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ... 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.