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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
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.
May 18, 2015 SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced ... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced C... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Ph... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compo... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advan... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Adv... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE,... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Co... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
May 18, 2015 HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Adv... Lack of Assurance of Sterility Class II Advanced Physician Solutions, Inc.
Apr 23, 2015 Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Comp... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) cap... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, ... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufac... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park ... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manu... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,00... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving,... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufa... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvin... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 23, 2015 Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufa... Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class II South Coast Specialty Compounding, Inc.
Apr 10, 2015 ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... Failed pH specification Class III Oasis Medical, Inc.
Mar 6, 2015 DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) Fuse... Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia... Class II Fusion Pharmaceuticals, LLC
Jan 6, 2015 Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags,... Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or... Class I Wallcur Incorporated
Dec 4, 2014 Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline H... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops (Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the C... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops Advanced Relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals Inc
Dec 4, 2014 Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (1... CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-... Class III K C Pharmaceuticals 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.