FDA Enforcement Database
Drug Safety & Recalls Center
Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.
Last Synchronized
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.
Latest Critical Safety Updates (Class I)
Recent FDA enforcement reports involving serious health risk classifications
Class I
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II (Moderate Risk)
Drug recall
Recall #: D-0361-2026
FIRST AID ONLY BZK ANTISEPTIC
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
Affected Product Description
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
Lots / Batch Codes & Expiration Dates
Lot #: MN12121, MN13521, Exp. Date Apr 2026; MN15221, MN16721, MN16921, MN17021, MN17021B, Exp. Date May 2026; MN18521, MN18621, MN18621B, Exp. Date Jun 2026; MN24721, MN25021, Exp. Date Aug 2026; MN01123, Exp. Date Dec 2027; MN27421, MN27721, Exp. Date Sep 2026; MN31321, MN31421, Exp. Date Oct 2026; MN34321, MN34521, MN34721, Exp. Date Nov 2026; M...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0384-2026
TEMOZOLOMIDE
Manufacturer / Recalling Firm: Rising Pharma Holding, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Affected Product Description
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Lots / Batch Codes & Expiration Dates
Lot #: 1TM0524003A, Exp. Date 09/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0380-2026
Semaglutide
Manufacturer / Recalling Firm: Harbin Jixianglong Biotech Co., Ltd.
Reason for Recall: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Affected Product Description
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
Lots / Batch Codes & Expiration Dates
Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0383-2026
MIDODRINE HYDROCHLORIDE
Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Defective container; inadequately sealed blister packaging.
Affected Product Description
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
Lots / Batch Codes & Expiration Dates
Lot # N02640, Exp Date: 08/2027
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall
Recall #: D-0376-2026
BZK PADS
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
Affected Product Description
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Lots / Batch Codes & Expiration Dates
Lot #: 53518, 53519, Exp. Date Jun 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0366-2026
MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
Affected Product Description
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.
Lots / Batch Codes & Expiration Dates
Lot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302...
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall
Recall #: D-0381-2026
NILOTINIB
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Affected Product Description
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Lots / Batch Codes & Expiration Dates
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0350-2026
C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0344-2026
Agebox iKids-Growth
Manufacturer / Recalling Firm: Agebox
Reason for Recall: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Affected Product Description
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
Lots / Batch Codes & Expiration Dates
Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028
Distribution Scope
The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
Class II (Moderate Risk)
Drug recall
Recall #: D-0348-2026
VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0345-2026
Agebox iKids-Growth
Manufacturer / Recalling Firm: Agebox
Reason for Recall: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Affected Product Description
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
Lots / Batch Codes & Expiration Dates
Lot # 23101202 exp 09/2026, 24080802 exp 07/2027, and 25020702 exp 01/2028
Distribution Scope
The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.
Class II (Moderate Risk)
Drug recall
Recall #: D-0349-2026
VISTA GONIO EYE LUBRICANT
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0339-2026
ADBRY
Manufacturer / Recalling Firm: LEO PHARMA INC
Reason for Recall: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Affected Product Description
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Lots / Batch Codes & Expiration Dates
Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0347-2026
VISTA HYPROMELLOSE DRY EYE RELIEF
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0341-2026
AMANTADINE HCL
Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Affected Product Description
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Lots / Batch Codes & Expiration Dates
Lot # 49261, Exp: 04/30/27
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall
Recall #: D-0343-2026
EPTIFIBATIDE
Manufacturer / Recalling Firm: Slate Run Pharmaceuticals
Reason for Recall: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Affected Product Description
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
Nationwide within the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0346-2026
Vista Tears Polyethylene Glycol 400 0.4% w/v
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0351-2026
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0352-2026
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Affected Product Description
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0307-2026
ESTRADIOL
Manufacturer / Recalling Firm: F.H. INVESTMENTS, Inc. (dba Asteria Health)
Reason for Recall: Presence of Foreign substance - potential presence of metal particulate matter
Affected Product Description
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Lots / Batch Codes & Expiration Dates
Lot#: 253000127, Exp. 06/09/2026; 253000133, Exp. 06/17/2026; 253000138, Exp. 07/14/2026; 253000141, Exp. 07/21/2026; 253000144, Exp. 07/28/2026; 253000147, Exp. 08/05/2026; 253000148, Exp. 08/07/2026; 253000149, Exp. 08/08/2026; 253000152, 253000153, Exp. 08/22/2026; 253000156, Exp. 09/03/2026; 253000157, Exp. 09/04/2026; 253000159, Exp. 09/05/20...
Distribution Scope
Nationwide in the USA