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 |
|---|---|---|---|---|
| Mar 24, 2022 | Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bot... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 24, 2022 | Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Pre... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 23, 2022 | Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx O... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 21, 2022 | SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled ... | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr... | Class I | Adamis Pharmaceuticals Corporation |
| Mar 21, 2022 | SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled... | Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephr... | Class I | Adamis Pharmaceuticals Corporation |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufact... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactu... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufact... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 16, 2022 | Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufac... | CGMP Deviations | Class II | Golden State Medical Supply Inc. |
| Mar 14, 2022 | PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a)... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vial... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials ... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 14, 2022 | TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Sin... | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that ... | Class II | Vitae Enim Vitae Scientific, Inc. |
| Mar 2, 2022 | Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR... | CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ... | Class II | Golden State Medical Supply Inc. |
| Feb 22, 2022 | Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... | CGMP deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Jan 25, 2022 | REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transfo... | Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated... | Class I | Blaine Labs Inc |
| Dec 3, 2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... | Class I | Gilead Sciences, Inc. |
| Nov 29, 2021 | Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx ... | Defective container: Out of specification for container integrity leading to bottles leaking. | Class II | Preferred Pharmaceuticals, Inc. |
| Oct 26, 2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... | Chemical Contamination: presence of benzene, acetaldehyde, and acetal. | Class I | VIRGIN SCENT INC |
| Oct 26, 2021 | artnaturals Hand Sanitizer | CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... | Class II | VIRGIN SCENT INC |
| Oct 26, 2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... | CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as t... | Class II | VIRGIN SCENT INC |
| Oct 14, 2021 | Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M... | Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu... | Class II | Golden State Medical Supply Inc. |
| Oct 14, 2021 | Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,... | Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... | Class II | Golden State Medical Supply Inc. |
| Oct 12, 2021 | Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... | Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 21, 2021 | Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chl... | CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or ... | Class II | Sanitor Corporation |
| Aug 2, 2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Je Dois Lavoir LLC |
| Jul 30, 2021 | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, R... | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmen... | Class II | Custopharm, Inc. |
| Jul 14, 2021 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. | Class I | Qikmoov LLC |
| Jun 22, 2021 | QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M... | Subpotent | Class II | HOYU(US) LOGISTICS INC |
| Jun 9, 2021 | Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For... | Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we... | Class II | Genentech Inc |
| May 11, 2021 | Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beau... | Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ing... | Class II | DASH XCLUSIVE |
| Apr 28, 2021 | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 ... | CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily In... | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 20, 2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total vo... | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA)... | Class III | Genentech Inc |
| Apr 12, 2021 | Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Susp... | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detec... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 19, 2021 | Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only,... | Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown i... | Class II | Golden State Medical Supply Inc. |
| Mar 19, 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli... | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ... | Class III | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
| Jan 27, 2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636... | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Jan 27, 2021 | Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... | Class II | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Jan 6, 2021 | Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F... | Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place... | Class II | DLC Laboratories, Inc |
| Dec 17, 2020 | ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (4... | Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast | Class I | NDAL Mfg Inc. |
| Nov 17, 2020 | ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... | FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... | Class II | Golden State Medical Supply Inc. |
| Nov 1, 2020 | Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage X... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... | Class II | Preferred Pharmaceuticals, Inc. |
| Oct 9, 2020 | N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bo... | Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. | Class II | Jarrow Formulas Inc |
| Oct 1, 2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL),... | Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleadin... | Class I | ASHTEL STUDIOS, INC. |
| Sep 2, 2020 | Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyr... | CGMP Deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Sep 2, 2020 | Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyr... | CGMP Deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Sep 2, 2020 | Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyron... | CGMP Deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Sep 2, 2020 | Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) ... | CGMP Deviations | Class II | Preferred 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.