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Browse Drug Recalls

198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 198 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 198 FDA drug recalls.

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DateProductReasonClassFirm
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
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 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
May 25, 2012 HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHE... 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 AMINOPHYLLINE 20ML, SDV** 500MG (25MG/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 BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/H... 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 CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1G... 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 FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 3... 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 / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 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 BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 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 AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 2... 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.