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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
May 25, 2012 CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 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 25, 2012 FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 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 25, 2012 ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 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 25, 2012 ENGERIX-B, SDV** 20MCG/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 EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HC... 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/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 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 AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 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 ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPRO... 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/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 Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distri... Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the ... Class II Kutol Products Co Inc
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

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.