Browse Drug Recalls

14,396 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,396 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 14,396 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Feb 12, 2016 Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only,... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 4... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, A... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 1... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 1... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 ... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 12, 2016 Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 4... Lack of Assurance of Sterility Class II Walter's Pharmacy
Feb 11, 2016 Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only... Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceedi... Class II Sun Pharma Global Fze
Feb 9, 2016 TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1... Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the pr... Class II Alcon Research, Ltd.
Feb 8, 2016 Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ... Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus au... Class II Keystone Laboratories Inc
Feb 5, 2016 Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuati... Defective Delivery System: Some units have actuation counters set to a number other than 60. Class II AstraZeneca Pharmaceuticals LP
Feb 5, 2016 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthca... PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identifi... Class II Baxter Healthcare Corp.
Feb 5, 2016 Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By... Failed Impurities/Degradation Specifications: Out of specification test results for impurities du... Class II Teva Pharmaceuticals USA
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, R... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ C... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Ph... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx o... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol.... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx onl... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pha... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml sy... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr P... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx on... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Phar... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharm... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Har... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Feb 4, 2016 Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, ... Lack of Assurance of Sterility Class II Hartley Medical Center Pharmacy, Incorporated
Jan 27, 2016 Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl ... Marketed without an approved NDA/ANDA Class II Bonita Pharmaceuticals, LLC
Jan 21, 2016 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of ste... Class II Baxter Healthcare Corp.
Jan 18, 2016 Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister car... Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Class II Amerisource Health Services
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrig... Labeling: label error on declared strength. Class II Perrigo Company PLC
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perri... Labeling: label error on declared strength. Class II Perrigo Company PLC

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.