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 |
|---|---|---|---|---|
| Jul 12, 2019 | Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-708... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jun 24, 2019 | Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torren... | Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Jun 24, 2019 | Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by To... | Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 13, 2019 | Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... | Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa pot... | Class II | B. Braun Medical Inc |
| Jun 10, 2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... | CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Preferred Pharmaceuticals, Inc |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx onl... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx o... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx on... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| Apr 30, 2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Preferred Pharmaceuticals, Inc |
| Apr 23, 2019 | Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display box... | Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. | Class I | D.B.P. Distribution |
| Mar 22, 2019 | Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building... | Failed pH Specification: product does not meet pH label claim. | Class III | Auro Pharmacies Inc. DBA Central Drugs |
| Mar 14, 2019 | Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingr... | Class I | Ata International Inc |
| Mar 6, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-0... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. | Class II | Preferred Pharmaceuticals, Inc |
| Mar 4, 2019 | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 m... | CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found ... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Feb 19, 2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL... | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead ... | Class II | Leiter's Enterprises, Inc. |
| Feb 14, 2019 | Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL... | Presence of Particulate Matter: Particulates observed in vials release for dispensing. | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Jan 25, 2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pru... | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared s... | Class I | Natures Rx |
| Jan 10, 2019 | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 m... | Presence of Particulate Matter: filmy/cloudy particulate observed in vial. | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Dec 11, 2018 | Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... | Class I | Asclemed USA Inc. dba Enovachem |
| Dec 11, 2018 | Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... | Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... | Class I | Asclemed USA Inc. dba Enovachem |
| Nov 5, 2018 | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... | Non-Sterility: Product manufactured under non-sterile production conditions. | Class I | Kadesh International |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Nov 2, 2018 | IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... | Class II | Golden State Medical Supply Inc. |
| Oct 18, 2018 | GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg... | Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 mont... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Oct 5, 2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90... | Container packaging defect. | Class III | Orexigen Therapeutics, Inc. |
| Aug 30, 2018 | Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum,... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Alkano Chemicals, Inc |
| Aug 23, 2018 | Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA | Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a phy... | Class II | Pacific Compounding Pharmacy & Consultations Inc |
| Aug 21, 2018 | Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central D... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, 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.