Browse Drug Recalls
268 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 268 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 268 FDA drug recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 4, 2026 | Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x... | Failed Impurities/Degradation Specifications - OOS impurities result observed during long term st... | Class II | SOMERSET THERAPEUTICS LLC |
| Feb 3, 2026 | Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactur... | Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin... | Class III | Annora Pharma Private Limited |
| 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) |
| 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 21, 2026 | Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed b... | Tablets/Capsules Imprinted with Wrong ID | Class III | Unichem Pharmaceuticals USA Inc. |
| Jan 21, 2026 | Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100... | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. | Class II | Unichem Pharmaceuticals USA Inc. |
| Jan 20, 2026 | Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium C... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sa... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, M... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box,... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per c... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towele... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Cu... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 pa... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wi... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
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.