Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 29, 2021 | Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net C... | Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans | Class I | Spartan Chemical Co Inc |
| Mar 29, 2021 | 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and ... | Class I | Nuri Trading LLC |
| Mar 29, 2021 | Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count bo... | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and ... | Class I | Nuri Trading LLC |
| Mar 29, 2021 | Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-... | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sild... | Class I | Nuri Trading LLC |
| Mar 29, 2021 | Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-... | Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an ... | Class I | Nuri Trading LLC |
| Mar 22, 2021 | TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Pre... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insu... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dos... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Pre... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefill... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose ... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Pre... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL a... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-do... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 19, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled stora... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled stor... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... | Class I | CareFusion 213, LLC |
| Mar 19, 2021 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... | Class I | CareFusion 213, LLC |
| Mar 17, 2021 | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: A... | Labeling: Label-mixup | Class I | Alembic Pharmaceuticals Limited |
| Mar 10, 2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... | Class I | Sanit Technologies, LLC dba Durisan |
| Mar 10, 2021 | Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... | Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... | Class I | Sanit Technologies, LLC dba Durisan |
| Mar 10, 2021 | heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, A... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | PNHC, LLC. |
| Mar 2, 2021 | Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle... | Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co... | Class I | A-S Medication Solutions LLC. |
| Feb 18, 2021 | Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For In... | Crystallization: customer complaints for crystallization in finished product. | Class I | Zydus Pharmaceuticals (USA) Inc |
| Feb 18, 2021 | Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For I... | Crystallization: customer complaints for crystallization in finished product. | Class I | Zydus Pharmaceuticals (USA) Inc |
| Feb 15, 2021 | Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distribute... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and ... | Class I | Adams.Secret.co |
| Feb 15, 2021 | Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distribute... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and ... | Class I | Adams.Secret.co |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut... | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m... | Class I | Apotex Corp. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati... | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12... | Class I | Apotex Corp. |
| Jan 27, 2021 | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos... | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t... | Class I | Meitheal Pharmaceuticals Inc |
| 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 15, 2021 | Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class I | Calvin Scott & Company, Inc. |
| Dec 23, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I | Fresenius Kabi USA, LLC |
| 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. |
| Dec 7, 2020 | TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manuf... | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... | Class I | AVKARE Inc. |
| Nov 25, 2020 | Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India f... | Failed Dissolution Specifications | Class I | Torrent Pharma Inc |
| Nov 17, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg... | Cross Contamination with other products: trace amounts of lidocaine | Class I | Fresenius Kabi USA, LLC |
| Nov 17, 2020 | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (... | Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated wit... | Class I | MPM Medical LLC |
| Oct 28, 2020 | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 m... | Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer ... | Class I | Lohxa LLC |
| Oct 27, 2020 | Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... | Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. | Class I | Sunstar Americas, Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in vari... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL... | Non-Sterility | Class I | Med Shop Total Care 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.