Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
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
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
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 15, 2016 progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room tempe... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx i... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit s... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, T... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit siz... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size,... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abb... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Comp... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size,... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, ... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, r... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016 papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit... Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... Class II Abbott's Compounding Pharmacy, Inc.

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.