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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 27, 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 25, 2018 | Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)... | Lack of Processing Controls: products produced in a manner that calls into question the sterility... | Class II | La Vita Compounding Pharmacy, LLC |
| Jun 25, 2018 | Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)... | Lack of Processing Controls: products produced in a manner that calls into question the sterility... | Class II | La Vita Compounding Pharmacy, LLC |
| Jun 25, 2018 | Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Wate... | Lack of Processing Controls: products produced in a manner that calls into question the sterility... | Class II | La Vita Compounding Pharmacy, LLC |
| Jun 11, 2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | BioDiagnostic International |
| May 25, 2018 | Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| Apr 24, 2018 | Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct f... | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... | Class II | Prescript Pharmaceuticals, Inc. |
| Apr 24, 2018 | Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannet... | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... | Class II | Prescript Pharmaceuticals, Inc. |
| Apr 24, 2018 | Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laborat... | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... | Class II | Prescript Pharmaceuticals, Inc. |
| Apr 24, 2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... | Class II | Prescript Pharmaceuticals, Inc. |
| Apr 24, 2018 | Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... | Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... | Class II | Prescript Pharmaceuticals, Inc. |
| Apr 12, 2018 | Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadal... | Class I | AMA Wholesale |
| Apr 10, 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Presence of Foreign Tablets/Capsules | Class III | Aidarex Pharmaceuticals LLC |
| Apr 2, 2018 | ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30... | CGMP Deviations: finished products were manufactured with poor quality water. | Class II | Diamond Wipes International, Inc. |
| Apr 2, 2018 | WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dis... | CGMP Deviations: finished products were manufactured with poor quality water. | Class II | Diamond Wipes International, Inc. |
| Mar 30, 2018 | PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... | Microbial Contamination of Non-Sterile Products | Class II | Marcas Usa Llc |
| Mar 29, 2018 | Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC ... | CGMP Deviations: the product was produced with substandard GMP manufacturing processes. | Class II | United Pacific Co Ltd |
| Mar 8, 2018 | Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pa... | Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tada... | Class I | Jimmy Weber |
| Feb 16, 2018 | 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PI... | Presence of Particulate Matter: Customer complaint of particulate matter which has been identifie... | Class II | B. Braun Medical Inc |
| Feb 14, 2018 | Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural ... | Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence... | Class I | Bella All Natural |
| Feb 5, 2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... | Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... | Class III | Genentech, Inc. |
| Dec 28, 2017 | Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe a... | Microbial Contamination of Non-Sterile Products. | Class II | DLC Laboratories, Inc |
| Dec 15, 2017 | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material... | Class II | B. Braun Medical Inc |
| Nov 29, 2017 | BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long B... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sil... | Class I | Blue Fusion Natural |
| Nov 28, 2017 | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titani... | CGMP Deviations: products manufactured in a manner that may impact product quality that includes ... | Class II | EAI-JR286 INC |
| Nov 9, 2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Class I | Kareway Products Inc |
| Sep 15, 2017 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packet... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distribute... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, ... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 15, 2017 | grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana See... | Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, d... | Class I | Gadget Island, Inc |
| Sep 13, 2017 | Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1... | Presence of particulate matter: glass flakes identified as lamellae observed during a routine qua... | Class II | Amgen, Inc. |
| 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 |
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.