Browse Drug Recalls
1,091 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,091 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 1,091 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2020 | Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ S... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Us... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABL... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 25... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/M... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML]... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Mult... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrig... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-d... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 14, 2020 | Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp.,... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Spectrum Laboratory Products |
| Jan 7, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Jan 7, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 co... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Jan 6, 2020 | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | H J Harkins Company Inc dba Pharma Pac |
| Dec 11, 2019 | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronize... | Subpotent Drug: Supplier indicated assay results did not meet specifications. | Class II | Spectrum Laboratory Products |
| Dec 9, 2019 | Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals,... | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... | Class II | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Dec 9, 2019 | Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals,... | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... | Class II | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Dec 9, 2019 | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals,... | Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impur... | Class II | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Dec 2, 2019 | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03),... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Nov 21, 2019 | Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferre... | Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert... | Class II | Preferred Pharmaceuticals, Inc |
| Nov 21, 2019 | EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 m... | Sub Potent Drug: Out of Specification (OOS) | Class II | Pacira Pharmaceuticals, Inc. |
| Nov 13, 2019 | Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 ma... | Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. | Class I | Natures Rx |
| Nov 12, 2019 | Albuterol 1.25mg / Ipratropium 0.5mg/ Budesonide 0.25mg, 3ML Vial, For Inhala... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Albuterol 2.5mg / Budesonide 0.5mg, 3ML Vial, For Inhalation Only, Shake Well... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg, 3ML Vial, For Inhala... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Albuterol 3.75mg / Ipratropium 0.75mg, 3ML Vial, For Inhalation Only, Convers... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Formoterol 12mcg / Budesonide 0.5mg, 3.5ML Vial, For Inhalation Only, Shake W... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
| Nov 12, 2019 | Albuterol 1.25mg / Ipratropium 0.5mg, 2ML Vial, For Inhalation Only, Conversi... | Lack of Processing Controls | Class II | Integrated Health Concepts Inc. dba Conversio H... |
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.