Browse Drug Recalls
515 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 515 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 515 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 | 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) |
| Jan 26, 2026 | Testosterone, 87.5 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, 25 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, 25.0 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 | Testosterone, 200 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, 100 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 2, 2026 | Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep ... | Presence of Particulate Matter. | Class II | Cipla USA, Inc. |
| Dec 22, 2025 | Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Ba... | Presence of particulate matter: plastic particles from the bottle rim were observed floating into... | Class II | Baxter Healthcare Corporation |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, ... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Ma... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 18, 2025 | Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 18, 2025 | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 18, 2025 | Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use... | Presence of particulate matter - Glass like particles. | Class II | Imprimis NJOF, LLC |
| Dec 12, 2025 | Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg,... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Dec 12, 2025 | Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Onl... | Presence of particulate matter: potential presence of metal particulates in the product. | Class II | Merck Sharp & Dohme LLC |
| Oct 14, 2025 | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSE... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FO... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, ... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUB... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSER... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERIL... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STER... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERIL... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY,... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 14, 2025 | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, Fa... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING 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.