FDA Recall
Ongoing
2026 recordClass II
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.
by ACME UNITED CORPORATION
- Reason
- CGMP Deviations
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1
by ACME UNITED CORPORATION
- Reason
- CGMP Deviations
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
by ACME UNITED CORPORATION
- Reason
- CGMP Deviations
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
by ACME UNITED CORPORATION
- Reason
- CGMP Deviations
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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,
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Wizcure Pharmaa Private Limited
- Reason
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
by Agebox
- Reason
- Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
by Agebox
- Reason
- Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
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
by Slate Run Pharmaceuticals
- Reason
- 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.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by AvKARE
- Reason
- Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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,
by LEO PHARMA INC
- Reason
- 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.
- Published
- March 4, 2026
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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