Browse Drug Recalls
14,572 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,572 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 14,572 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 28, 2026 | Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, R... | Failed Content Uniformity Specifications | Class II | Preferred Pharmaceuticals, Inc. |
| Sep 24, 2026 | Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, A... | Lack of Assurance of Sterility | Class II | Apothecary Pharma LLC |
| Sep 24, 2026 | Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothe... | Lack of Assurance of Sterility | Class II | Apothecary Pharma LLC |
| Sep 23, 2026 | IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-d... | Presence of particulate matter. | Class II | J&J INNOVATIVE MEDICINE |
| Sep 23, 2026 | Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufa... | Failed dissolution specifications. | Class II | Apotex Corp. |
| Sep 18, 2026 | Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of... | Failed Impurities/Degradation Specifications | Class II | Cipla USA, Inc. |
| Sep 17, 2026 | Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marke... | Failed Dissolution Specifications: below specification | Class II | Ajanta Pharma USA Inc |
| Sep 17, 2026 | FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manuf... | Lack of Assurance of Sterility | Class II | Aurolab Trust |
| Sep 15, 2026 | Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.2... | Lack of Assurance of Sterility | Class II | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Sep 15, 2026 | Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.2... | Lack of Assurance of Sterility | Class II | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Sep 11, 2026 | Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lu... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange s... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ ... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 11, 2026 | Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DIS... | Lack of Assurance of Sterility | Class II | K.C. Pharmaceuticals, Inc. |
| Sep 10, 2026 | SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 9... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosa... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosag... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, tota... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosa... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosa... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosa... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dos... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use do... | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dos... | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use do... | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use do... | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosa... | Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to proce... | Class II | Carolina Infusion, LLC |
| Sep 10, 2026 | QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage... | Lack of Assurance of Sterility: Related to processing equipment used in compounded product. | Class II | Carolina Infusion, LLC |
| Sep 8, 2026 | Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Do... | Crystallization | Class II | Par Health USA, LLC |
| Sep 8, 2026 | Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by:... | Defective Container; packets were found to be either empty or partially full. | Class II | Amneal Pharmaceuticals, LLC |
| Sep 4, 2026 | Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials pe... | Lack of Assurance of Sterility | Class II | Pfizer |
| Sep 3, 2026 | Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufact... | Failed Dissolution Specifications | Class II | Inventia Healthcare Limited |
| Sep 3, 2026 | fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0... | Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of... | Class II | OurPharma LLC |
| Sep 1, 2026 | Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Labor... | Microbial contamination of topical product. | Class II | SV Labs Toronto Corporation |
| Sep 1, 2026 | Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0... | Microbial contamination of topical product. | Class II | SV Labs Toronto Corporation |
| Aug 31, 2026 | Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a car... | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor c... | Class II | TerSera Therapeutics LLC |
| Aug 31, 2026 | Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Tar... | Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 2... | Class II | SUN PHARMA /TARO |
| Aug 28, 2026 | Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subc... | Defective Delivery System: Possibility of no medication in the prefilled pen. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Aug 26, 2026 | Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile,... | Failed Dissolution Specifications | Class II | Mylan Pharmaceuticals Inc |
| Aug 24, 2026 | traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactur... | Presence of Foreign Tablets/Capsules | Class II | Teva Pharmaceuticals USA, Inc |
| Aug 24, 2026 | Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) ... | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclo... | Class II | Hikma Pharmaceuticals USA INC. |
| Aug 21, 2026 | Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSM... | Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled ... | Class II | Golden State Medical Supply Inc. |
| Aug 21, 2026 | Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (C... | CGMP Deviations: Potential contamination of raw material | Class II | Lexia LLC |
| Aug 21, 2026 | Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Iso... | CGMP Deviations: Potential contamination of raw material | Class II | Lexia 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.