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 |
|---|---|---|---|---|
| Sep 5, 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhard... | Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lo... | Class III | Aidarex Pharmaceuticals LLC |
| Sep 5, 2017 | Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with... | Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. | Class I | Genentech, Inc. |
| Sep 5, 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... | Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... | Class III | Aidarex Pharmaceuticals LLC |
| Aug 29, 2017 | PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, ... | Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone. | Class I | Lucky Mart Inc. |
| Aug 15, 2017 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose ... | Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of re... | Class II | Amphastar Pharmaceuticals, Inc. |
| Aug 4, 2017 | Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subc... | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product ... | Class II | Amgen, Inc. |
| Jul 12, 2017 | Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... | CGMP Deviations | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jun 23, 2017 | Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Sl... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Dr... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml B... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 23, 2017 | Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Com... | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a misl... | Class II | ImprimisRx CA, Inc., dba ImprimisRx |
| Jun 22, 2017 | MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sild... | Class I | Vitility |
| Apr 18, 2017 | BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, suppli... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 co... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg val... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied i... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, suppl... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count pa... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplie... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, ... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 1... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 18, 2017 | ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsu... | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, s... | Class I | Organic Herbal Supply |
| Apr 13, 2017 | Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.000000000000... | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... | Class I | Standard Homeopathic Company |
| Apr 13, 2017 | Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HP... | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ... | Class I | Standard Homeopathic Company |
| Mar 13, 2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Swit... | Superpotent Drug: An oversized tablet was found in a bottle. | Class II | Genentech Inc. |
| Feb 16, 2017 | SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged i... | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... | Class II | Sato Pharmaceutical Inc. |
| Feb 16, 2017 | DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL)... | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... | Class II | Sato Pharmaceutical Inc. |
| Feb 16, 2017 | XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg ... | Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tada... | Class I | Organic Herbal Supply |
| Feb 16, 2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15... | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... | Class II | Sato Pharmaceutical Inc. |
| Feb 10, 2017 | TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETIN... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA ... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arb... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only,... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx ... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 49... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / P... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A Sa... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, ... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, S... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx on... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
| Feb 10, 2017 | BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd #... | Lack of Assurance of Sterility: There are also CGMP Deviations. | Class II | Synergy Rx |
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.