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Browse Drug Recalls

1,076 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,076 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 1,076 FDA drug recalls in CA.

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DateProductReasonClassFirm
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 Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manuf... Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. Class I Master Herbs, Inc./Li
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.
Dec 11, 2015 FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-c... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... Class I Reesna, Inc
Dec 11, 2015 FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bo... Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... Class I Reesna, Inc
Nov 25, 2015 MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Onl... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Golden State Medical Supply Inc.
Nov 25, 2015 MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 6... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Golden State Medical Supply Inc.
Oct 19, 2015 HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 19, 2015 HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 19, 2015 HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe,... Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... Class III Oasis Medical, Inc.
Oct 7, 2015 Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B &... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, B... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflowe... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pha... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Ph... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health M... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflow... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflow... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 7, 2015 PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II Pacific Healthcare, Inc dba B&B Pharmacy
Oct 6, 2015 TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 2... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Ph... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015 METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280... Lack of Assurance of Sterility: all sterile compounded products within expiry Class II Chen Shwezin, Inc. dba Park 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.