Browse Drug Recalls
1,110 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,110 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 1,110 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 6, 2015 | TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL 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 1, 2015 | Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... | Class I | MSNV, Inc dba National Video Supply |
| Oct 1, 2015 | Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... | Class I | MSNV, Inc dba National Video Supply |
| Sep 30, 2015 | Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... | Class I | Premiere Sales Group |
| Sep 30, 2015 | Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie... | Class I | Premiere Sales Group |
| Aug 31, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Falied pH specification | Class III | Oasis Medical, Inc. |
| Aug 17, 2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupi... | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... | Class I | Hartley Medical Center Pharmacy, Incorporated |
| Aug 17, 2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 1... | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... | Class I | Hartley Medical Center Pharmacy, Incorporated |
| Aug 11, 2015 | METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured b... | Presence of Foreign Substance: Presence of hair. | Class III | Golden State Medical Supply Inc. |
| Jun 12, 2015 | PYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrit... | Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a pres... | Class I | GC Natural Nutrition, Inc. |
| May 18, 2015 | GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy,... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced ... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Adva... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compoundi... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compo... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, Inc. |
| May 18, 2015 | SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced C... | Lack of Assurance of Sterility | Class II | Advanced Physician Solutions, 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.