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Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
Oct 22, 2013 Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured ... Cross Contamination with Other Products: findings of carryover of trace amounts of a previously m... Class II Sandoz Incorporated
Oct 21, 2013 Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For ... Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was fo... Class I Medisca Inc.
Oct 19, 2013 FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compou... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medici... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compoundi... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Comp... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL IN... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy,... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH ... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Co... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Com... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medic... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Med... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty M... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compo... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Me... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty M... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/m... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specia... Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold,... Class I Specialty Medicine Compounding Pharmacy, P.C.
Oct 19, 2013 Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Med... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compoundi... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cu... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compou... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medici... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medic... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compoundin... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/m... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medici... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compoun... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medic... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJEC... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compo... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Special... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compoun... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 m... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx o... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Comp... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Ph... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tr... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding ... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Me... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding ... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding P... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy

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.