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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2012 | VANADYL SULFATE SOLUTION 200MCG/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 21, 2012 | MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/... | 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 21, 2012 | VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 KIT ... | 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 21, 2012 | TWINJECT*** 0.3 MG INJECTABLE 1 PK (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 21, 2012 | PENICILLIN G POTASSIUM 10,000U/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 21, 2012 | PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPH... | 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 21, 2012 | IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 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 21, 2012 | PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 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 21, 2012 | VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) 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 21, 2012 | L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 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 21, 2012 | TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 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 21, 2012 | MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR 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 21, 2012 | LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 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 21, 2012 | RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. ... | 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 21, 2012 | INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/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 21, 2012 | TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/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 21, 2012 | METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOB... | 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 21, 2012 | TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, ... | 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 21, 2012 | PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 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 21, 2012 | TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 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 21, 2012 | LORAZEPAM 2MG/ML INJECTABLE 10 ML 20 ML 200 ML (3 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 21, 2012 | VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 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 21, 2012 | VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC... | 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 21, 2012 | SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% 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 21, 2012 | METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% 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 21, 2012 | ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 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 21, 2012 | ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 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 21, 2012 | PAPAVERINE/ALPROSTADIL 30MG/10MCG/ML INJECTABLE 10 ML; PAPAVERINE/ALPROSTADI... | 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 21, 2012 | MITOMYCIN 1MG/ML SOLUTION 160 ML 40 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 21, 2012 | PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 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 21, 2012 | MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 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 21, 2012 | PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML; PROCAINE HCL, P.F. 2% INJ... | 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 21, 2012 | ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 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 21, 2012 | LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLU... | 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 21, 2012 | POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 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 21, 2012 | TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT ... | 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 21, 2012 | METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 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 21, 2012 | IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 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 21, 2012 | PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 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 21, 2012 | NADH-FFC 10 MG/CC 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 21, 2012 | MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODU... | 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 21, 2012 | TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMC... | 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 21, 2012 | STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 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 21, 2012 | TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYP... | 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 21, 2012 | MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MAN... | 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 21, 2012 | LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE 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 21, 2012 | LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 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 21, 2012 | TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCI... | 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.