Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 31, 2021 | IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 71812... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... | Class II | QMart |
| Mar 31, 2021 | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 ... | Microbial Contamination of Non-Sterile Product | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 30, 2021 | Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... | Class II | Na Na Collection |
| Mar 30, 2021 | Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count ... | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... | Class I | Ummzy, LLC |
| Mar 30, 2021 | Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, M... | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... | Class I | Ummzy, LLC |
| Mar 30, 2021 | PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 ... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... | Class II | Na Na Collection |
| Mar 30, 2021 | Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in ... | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... | Class I | Ummzy, LLC |
| Mar 29, 2021 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Conte... | CGMP Deviations | Class II | 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 | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Content... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.7... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| 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 | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| 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 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... | Failed Stability Specifications: product did not meet viscosity results. | Class III | Teligent Pharma, Inc. |
| 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 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Conten... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| 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 26, 2021 | Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC.... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and ... | Class II | Antoto-K |
| Mar 26, 2021 | Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixe... | Superpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Mar 25, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottl... | Failed Moisture Limits: Out of specification for water content | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-... | CGMP Deviaitons | Class II | Cosette Pharmaceuticals, Inc. |
| Mar 25, 2021 | Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and s... | Class II | S & B Story LLC |
| Mar 25, 2021 | PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distr... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and s... | Class II | Namoo Enterprise LLC |
| Mar 24, 2021 | Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UP... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and ... | Class II | Bit & Bet LLC |
| Mar 22, 2021 | Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class II | 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 | OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pe... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class II | Novo Nordisk Inc |
| Mar 22, 2021 | ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pe... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class II | 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 22, 2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III | Macleods Pharma Usa 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 | 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 | 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 | 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 | 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 | 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 | 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) 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 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 Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... | Class II | CareFusion 213, LLC |
| 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 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... | Class II | 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 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| 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 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, M... | Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological ... | Class II | X-Gen Pharmaceuticals 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 |
| 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 19, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
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.