Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 4, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bo... | Presence of foreign substance: identified as activated carbon. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 3, 2021 | Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx onl... | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Class II | Pfizer Inc. |
| Apr 29, 2021 | Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manu... | Subpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Apr 28, 2021 | Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North Amer... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 ... | CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily In... | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 26, 2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 16, 2021 | Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, ... | Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... | Class II | Noven Pharmaceuticals Inc |
| Apr 16, 2021 | Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box... | Defective Delivery System: Out of specification for release rate testing and shear, an attribute ... | Class II | Noven Pharmaceuticals Inc |
| Apr 15, 2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medi... | cGMP deviations | Class II | Grace Healthcare Medical, Inc |
| Apr 14, 2021 | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a... | Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. | Class II | Fresenius Medical Care, North America |
| Apr 12, 2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, ... | Defective container; syringe content migrating past the seal of the plunger may cause a lack of a... | Class II | Edge Pharma, LLC |
| Apr 12, 2021 | Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Susp... | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detec... | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 9, 2021 | Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pha... | Failed Impurities/Degradation Specifications: | Class II | Teligent Pharma, Inc. |
| Apr 6, 2021 | PremierZen Extreme 3000, packaged in cardboard blisters containing one caps... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Class II | Hyobin LLC |
| Apr 6, 2021 | PremierZen Black 5000, packaged in cardboard blisters containing one capsul... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Class II | Hyobin LLC |
| Apr 6, 2021 | Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one ... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil. | Class II | Hyobin LLC |
| Apr 1, 2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... | Failed Dissolution Specifications | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 31, 2021 | Imperial Platinum 2000, 1 capsule, UPC 718122040702 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... | Class II | QMart |
| Mar 31, 2021 | Burro en Primavera, 2 capsules, UPC 638632431055 | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... | Class II | QMart |
| Mar 31, 2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... | Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiap... | Class II | Apotex Corp. |
| Mar 31, 2021 | PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC ... | Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... | Class II | QMart |
| 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 | 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 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 Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| 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 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Conte... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Conten... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| 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 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 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 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 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 | 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 | 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 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 | 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 |
| 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 | 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 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 15, 2021 | LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT O... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health 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.