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 | METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500... | 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/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 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 | METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML; METHYLPREDNIS... | 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 | OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 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 |
| May 21, 2012 | THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PR... | 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/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 6... | 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 | TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 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 | RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 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 | POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 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 | RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 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 | PANTOTHENIC ACID 1MG/ML INJECTABLE 30 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 | METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 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 | RUBIDIUM 200MCG/ML INJECTABLE 30 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 | LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 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 | PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL ... | 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 | MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJEC... | 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 | THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 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 | ZINC CHLORIDE 10MG/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 | QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/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 | PACLITAXEL 6MG/ML INJECTABLE 500 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 | THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG ... | 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 | PREDNISOLONE ACETATE 10MG/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 21, 2012 | TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MC... | 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/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ... | 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 | SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 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 | POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLO... | 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 HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRIN... | 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 | PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE 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 | TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 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 | MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 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 | LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% 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 21, 2012 | LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 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 | NANDROLONE DECANOATE (H) 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 | KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; K... | 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 | SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 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 | TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 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 | KENALOG-40** (MDV 10ML VIAL) 40MG/ML 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 21, 2012 | MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) 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 21, 2012 | SESAME OPHTHALMIC OIL 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 | LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 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 | METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 20... | 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-TRYPTOPHAN 15MG/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 | MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 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 | PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 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 | LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL ... | 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 | PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 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 | VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K ... | 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 | WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE... | 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 | MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 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 | MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFF... | 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.