Browse Drug Recalls
14,127 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,127 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 14,127 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2026 | Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... | Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Feb 26, 2026 | Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Vall... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 26, 2026 | Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W... | Lack of Assurance of Sterility | Class II | New Life Pharma LLC |
| Feb 24, 2026 | Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs... | Failed Dissolution Specifications | Class II | MYLAN PHARMACEUTICALS INC |
| Feb 18, 2026 | MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal S... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 18, 2026 | MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 18, 2026 | FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz... | Stability Data Does Not Support Expiry Date. | Class II | HTO Nevada Inc. dba Kirkman |
| Feb 17, 2026 | Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs)... | Defective container; inadequately sealed blister packaging. | Class II | The Harvard Drug Group LLC |
| Feb 13, 2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01... | CGMP Deviations This recall has been initiated due to failing to complete process validation and ... | Class II | Harbin Jixianglong Biotech Co., Ltd. |
| Feb 13, 2026 | Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Onl... | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification ... | Class II | AvKARE |
| Feb 13, 2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-0... | CGMP Deviations This recall has been initiated due to failing to complete process validation and ... | Class II | Harbin Jixianglong Biotech Co., Ltd. |
| Feb 10, 2026 | Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single d... | Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lo... | Class II | LEO PHARMA INC |
| Feb 9, 2026 | Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx... | Defective Delivery System: Missing or duplicated needles within the injection kit | Class II | Meitheal Pharmaceuticals, Inc |
| Feb 5, 2026 | acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injecti... | Lack of Assurance of Sterility | Class II | Fresenius Kabi Compounding, LLC |
| Feb 5, 2026 | vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Inject... | Lack of Assurance of Sterility | Class II | Fresenius Kabi Compounding, LLC |
| Feb 5, 2026 | vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride In... | Lack of Assurance of Sterility | Class II | Fresenius Kabi Compounding, LLC |
| Feb 5, 2026 | ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride... | Lack of Assurance of Sterility | Class II | Fresenius Kabi Compounding, LLC |
| Feb 5, 2026 | thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection,... | Lack of Assurance of Sterility | Class II | Fresenius Kabi Compounding, LLC |
| Feb 2, 2026 | Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4... | cGMP deviations | Class II | Pro Numb Tattoo Numbing Spray LLC |
| Feb 2, 2026 | Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL]... | cGMP deviations | Class II | Pro Numb Tattoo Numbing Spray LLC |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets b... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, R... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (ND... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 29, 2026 | Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (ND... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 27, 2026 | Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharma... | Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] resul... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 26, 2026 | ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingh... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Indu... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Ind... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birming... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial,... | Presence of Particulate Matter: Due to production issues | Class II | Radnostix |
| Jan 26, 2026 | Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Aster... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birming... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Bi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Bi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingh... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Bi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria ... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Bir... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 4... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Bi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured ... | Presence of Foreign Tablets/Capsules | Class II | Granules Pharmaceuticals Inc. |
| Jan 26, 2026 | Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Bi... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birming... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria ... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
| Jan 26, 2026 | ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birming... | Presence of Foreign substance - potential presence of metal particulate matter | Class II | F.H. INVESTMENTS, Inc. (dba Asteria Health) |
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.