Browse Drug Recalls
88 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 88 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 88 FDA drug recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jan 20, 2026 | Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme Unit... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette,... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, M... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wi... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.1... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, b... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 p... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelett... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 16, 2026 | Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repac... | Subpotent Drug | Class II | Specialty Process Labs LLC |
| Jan 16, 2026 | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syrin... | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrect... | Class I | McKesson |
| Jan 15, 2026 | methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton cont... | Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blis... | Class II | Greenstone Llc |
| Jan 14, 2026 | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) bliste... | Defective container: Multiple customer complaints received for card seal defects observed on the ... | Class II | Amerisource Health Services LLC |
| Jan 10, 2026 | Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Risi... | Presence of Foreign Substance | Class II | Graviti Pharmaceuticals Private Limited |
| Jan 6, 2026 | AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each | cGMP deviations. | Class II | Encon Safety Products Co |
| 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. |
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.