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.

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DateProductReasonClassFirm
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 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 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.
Dec 31, 2025 CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per ... Out of specification for dissolution. Class II AvKARE
Dec 31, 2025 Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only,... Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets ... Class II Alvogen, Inc
Dec 31, 2025 Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drop... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye D... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manu... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 31, 2025 BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manuf... Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... Class II Wizcure Pharmaa Private Limited
Dec 30, 2025 Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by... Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsule... Class II Zydus Pharmaceuticals (USA) Inc
Dec 30, 2025 Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercar... Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... Class II Glenmark Pharmaceuticals Inc., USA
Dec 26, 2025 Benadryl, 25'S 2PK Box, UPC 815556020316 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 8155560... CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 DAYQUIL COLD & FLU, 32CT/2PK CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 PEPCID COMPLETE - 25CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Bayer 2Pk- 25 CT CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Claritin, 20 Count, UPC: 655708016305 CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution c... Class II GOLD STAR DISTRIBUTION 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.