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Browse Drug Recalls

43 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 43 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 43 FDA drug recalls.

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DateProductReasonClassFirm
Jan 15, 2016 calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's C... 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 Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, 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; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 m... 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/20 mcg/mL; 5 mL unit size, re... 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/20 mcg/mL; 5 mL and 10 mL un... 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, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Ab... 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/30 mcg/mL, 5 mL unit size, refrigerate, This 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, 35 mg/2.5 mg/mL; 5 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 papaverine phentolamine prostaglandin; 12/1 mg/9 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.
Jan 15, 2016 Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott'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 Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharm... 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; 30/1.5 mg/40 mcg/mL; 5 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; 35/1.2 mg/20 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 mg/0.25 mg/10 mcg/mL; 10 mL unit si... 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, 10 mg/mL, 6 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; 35/1.5 mg/50 mcg/mL, 5 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; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL u... 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 10 mg/mL, 10 mL and 12 mL unit sizes, 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 Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compou... 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 4 mg/mL, 5 mL and 30 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/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.
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 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; 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 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; 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 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; 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 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 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; 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 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 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; 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 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 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; 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 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 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 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 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; 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 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.

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.