Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0357-2026 | 01-29-2026 | Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11 Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 19,056 bottles | Class II | Ongoing |
| D-0355-2026 | 01-29-2026 | 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 Package NDCs: 45963-709-11; 45963-709-96; 45963-676-11; 45963-676-96; 45963-677-11; 45963-677-96; 45963-678-11 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 67,043 bottles | Class II | Ongoing |
| D-0342-2026 | 01-27-2026 | Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 Package NDCs: 51672-1363-3; 51672-1363-7 | Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0305-2026 | 01-26-2026 | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. Package NDCs: 70010-231-03; 70010-231-01; 70010-231-05; 70010-231-10; 70010-232-03; 70010-232-01; 70010-232-05; 70010-232-10; 70010-233-03; 70010-233-01; 70010-233-05; 70010-234-03; 70010-234-01; 70010-234-05 | Presence of Foreign Tablets/Capsules | Granules Pharmaceuticals Inc. / 71424 bottles. | Class II | Ongoing |
| D-0322-2026 | 01-26-2026 | Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 62,581 pellets. | Class II | Ongoing |
| D-0314-2026 | 01-26-2026 | ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 2,442 pellets. | Class II | Ongoing |
| D-0317-2026 | 01-26-2026 | Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 146 pellets | Class II | Ongoing |
| D-0309-2026 | 01-26-2026 | ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 22,478 pellets. | Class II | Ongoing |
| D-0325-2026 | 01-26-2026 | Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,015 pellets | Class II | Ongoing |
| D-0310-2026 | 01-26-2026 | ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 14,848 pellets | Class II | Ongoing |
| D-0320-2026 | 01-26-2026 | Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 70,959 pellets. | Class II | Ongoing |
| D-0324-2026 | 01-26-2026 | Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 194,336 pellets | Class II | Ongoing |
| D-0315-2026 | 01-26-2026 | ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 715 pellets | Class II | Ongoing |
| D-0321-2026 | 01-26-2026 | Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,758 pellets. | Class II | Ongoing |
| D-0313-2026 | 01-26-2026 | ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 133 pellets | Class II | Ongoing |
| D-0319-2026 | 01-26-2026 | Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 60,868 pellets. | Class II | Ongoing |
| D-0326-2026 | 01-26-2026 | Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 100 pellets | Class II | Ongoing |
| D-0331-2026 | 01-26-2026 | Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32 | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,464 pellets. | Class II | Ongoing |
| D-0311-2026 | 01-26-2026 | ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,699 pellets | Class II | Ongoing |
| D-0307-2026 | 01-26-2026 | ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 50,990 pellets | Class II | Ongoing |
| D-0318-2026 | 01-26-2026 | Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 89,074 pellets | Class II | Ongoing |
| D-0316-2026 | 01-26-2026 | Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 3,871 pellets | Class II | Ongoing |
| D-0389-2026 | 01-26-2026 | Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID. Package NDCs: 69208-000-00; 69208-003-15; 69208-003-25; 69208-003-35 | Presence of Particulate Matter: Due to production issues | Radnostix / 16 units | Class II | Ongoing |
| D-0330-2026 | 01-26-2026 | Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,631 pellets | Class II | Ongoing |
| D-0329-2026 | 01-26-2026 | Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 7,840 pellets | Class II | Ongoing |
| D-0328-2026 | 01-26-2026 | Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 4,599 pellets | Class II | Ongoing |
| D-0327-2026 | 01-26-2026 | Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 670 pellets | Class II | Ongoing |
| D-0312-2026 | 01-26-2026 | ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 1,475 pellets | Class II | Ongoing |
| D-0323-2026 | 01-26-2026 | Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 153,498 pellets | Class II | Ongoing |
| D-0308-2026 | 01-26-2026 | ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32. | Presence of Foreign substance - potential presence of metal particulate matter | F.H. INVESTMENTS, Inc. (dba Asteria Health) / 24,099 pellets | Class II | Ongoing |
| D-0306-2026 | 01-21-2026 | Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10. Package NDCs: 29300-351-13; 29300-351-01; 29300-351-10; 29300-352-13; 29300-352-01; 29300-352-10; 29300-353-13; 29300-353-01; 29300-353-10; 29300-354-13; 29300-354-01; 29300-354-10 | Tablets/Capsules Imprinted with Wrong ID | Unichem Pharmaceuticals USA Inc. / 60,000 tablets | Class III | Ongoing |
| D-0301-2026 | 01-21-2026 | Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01 Package NDCs: 29300-187-13; 29300-187-01; 29300-187-05; 29300-187-10; 29300-188-13; 29300-188-01; 29300-188-05; 29300-188-10; 29300-189-13; 29300-189-01; 29300-189-05; 29300-189-10 | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. | Unichem Pharmaceuticals USA Inc. / N/A | Class II | Ongoing |
| D-0365-2026 | 01-20-2026 | Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33. Package NDCs: 47682-122-99; 47682-122-71; 47682-122-33; 47682-252-99; 47682-252-71 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0362-2026 | 01-20-2026 | 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0375-2026 | 01-20-2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01 Package NDCs: 67777-245-01; 67777-245-11; 67777-245-02; 67777-245-14; 67777-245-04; 67777-245-15; 67777-245-05; 67777-245-06; 67777-245-16; 67777-245-08; 67777-245-18; 67777-245-07; 67777-245-17 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0373-2026 | 01-20-2026 | Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00 Package NDCs: 0924-0301-00; 0924-0301-04; 0924-0301-05 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0371-2026 | 01-20-2026 | Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01. Package NDCs: 0924-0243-00; 0924-0243-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0361-2026 | 01-20-2026 | 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. Package NDCs: 0924-7116-00; 0924-7116-04; 0924-7116-05; 0924-7116-03; 0924-7116-01; 0924-7116-02 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0372-2026 | 01-20-2026 | WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01. | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0359-2026 | 01-20-2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03. Package NDCs: 0924-7116-00; 0924-7116-04; 0924-7116-05; 0924-7116-03; 0924-7116-01; 0924-7116-02 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0367-2026 | 01-20-2026 | BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02. Package NDCs: 0924-0246-00; 0924-0246-01; 0924-0246-02; 0924-0246-03 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0376-2026 | 01-20-2026 | 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. Package NDCs: 67777-245-01; 67777-245-11; 67777-245-02; 67777-245-14; 67777-245-04; 67777-245-15; 67777-245-05; 67777-245-06; 67777-245-16; 67777-245-08; 67777-245-18; 67777-245-07; 67777-245-17 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0369-2026 | 01-20-2026 | Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02 Package NDCs: 67777-244-02; 67777-244-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0370-2026 | 01-20-2026 | Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00. Package NDCs: 0924-0243-00; 0924-0243-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0364-2026 | 01-20-2026 | Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0368-2026 | 01-20-2026 | Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01. | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0366-2026 | 01-20-2026 | 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. Package NDCs: 0924-0246-00; 0924-0246-01; 0924-0246-02; 0924-0246-03 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0363-2026 | 01-20-2026 | Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0374-2026 | 01-20-2026 | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73 Package NDCs: 47682-056-99; 47682-056-73; 47682-056-33 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0358-2026 | 01-20-2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04 Package NDCs: 0924-7116-00; 0924-7116-04; 0924-7116-05; 0924-7116-03; 0924-7116-01; 0924-7116-02 | CGMP Deviations | ACME UNITED CORPORATION / 212,607,900 containers | Class II | Ongoing |
| D-0377-2026 | 01-20-2026 | Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0378-2026 | 01-20-2026 | Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00. | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0360-2026 | 01-20-2026 | 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 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0294-2026 | 01-16-2026 | Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 | Subpotent Drug | Specialty Process Labs LLC / 58 gms | Class II | Ongoing |
| D-0353-2026 | 01-16-2026 | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 Package NDCs: 69448-025-63; 69448-026-63; 69448-027-63 | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. | McKesson / 116 cartons | Class I | Ongoing |
| D-0299-2026 | 01-15-2026 | methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 Package NDCs: 59762-4440-3; 59762-4440-2; 59762-0049-1; 59762-0050-1; 59762-0051-1 | Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. | Greenstone Llc / 3456 cartons | Class II | Ongoing |
| D-0338-2026 | 01-14-2026 | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11 Package NDCs: 68084-354-11; 68084-354-01; 68084-968-11; 68084-968-01; 68084-975-11; 68084-975-01; 68084-983-11; 68084-983-01 | Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. | Amerisource Health Services LLC / 31,676 packages | Class II | Ongoing |
| D-0445-2026 | 01-12-2026 | Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack). Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent and Subpotent | Teva Pharmaceuticals USA, Inc / 21984 packages | Class II | Ongoing |
| D-0446-2026 | 01-12-2026 | Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack). Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent and Subpotent | Teva Pharmaceuticals USA, Inc / 8376 packages | Class II | Ongoing |
| D-0293-2026 | 01-10-2026 | Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. Package NDCs: 64980-562-01; 64980-562-10; 64980-563-01; 64980-563-10; 64980-564-01; 64980-564-50 | Presence of Foreign Substance | Graviti Pharmaceuticals Private Limited / 4212 bottles | Class II | Ongoing |
| D-0260-2026 | 01-06-2026 | AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each | cGMP deviations. | Encon Safety Products Co / 7677 bags | Class II | Ongoing |
| D-0290-2026 | 01-02-2026 | Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67 Package NDCs: 69097-880-67; 69097-890-67; 69097-870-67 | Presence of Particulate Matter. | Cipla USA, Inc. / 15,221 syringes | Class II | Ongoing |
| D-0347-2026 | 12-31-2025 | 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. Package NDCs: 77790-002-10 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 17,280 cartons | Class II | Ongoing |
| D-0352-2026 | 12-31-2025 | 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:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 184,320 containers | Class II | Ongoing |
| D-0350-2026 | 12-31-2025 | 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, Package NDCs: 83851-100-10; 83851-100-30; 83851-100-05 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 10,080 boxes | Class II | Ongoing |
| D-0348-2026 | 12-31-2025 | 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. Package NDCs: 77790-003-10 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 11,520 cartons | Class II | Ongoing |
| D-0346-2026 | 12-31-2025 | 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. | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 5,760 cartons | Class II | Ongoing |
| D-0351-2026 | 12-31-2025 | 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:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 50,400 Boxes | Class II | Ongoing |
| D-0349-2026 | 12-31-2025 | 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. Package NDCs: 77790-022-15 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 139,104 cartons | Class II | Ongoing |
| D-0259-2026 | 12-31-2025 | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10. | Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. | Alvogen, Inc / | Class II | Ongoing |
| D-0292-2026 | 12-31-2025 | Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 Package NDCs: 50268-709-11; 50268-709-15; 50268-710-11; 50268-710-15; 50268-711-11; 50268-711-15 | Out of specification for dissolution. | AvKARE / 7,991 5x10 cartons | Class II | Ongoing |
| D-0295-2026 | 12-30-2025 | Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 | Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules | Zydus Pharmaceuticals (USA) Inc / 22,896 bottles | Class II | Ongoing |
| D-0246-2026 | 12-30-2025 | Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13 Package NDCs: 68462-105-33; 68462-105-30; 68462-106-33; 68462-106-30; 68462-157-13; 68462-158-11; 68462-158-13 | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. | Glenmark Pharmaceuticals Inc., USA / 96,948 packs | Class II | Ongoing |
| D-0256-2026 | 12-30-2025 | Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4 Package NDCs: 51672-1365-2; 51672-1365-4 | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. | SUN PHARMACEUTICAL INDUSTRIES INC / 24,624 bottles | Class III | Ongoing |
| D-0524-2026 | 12-27-2025 | TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670 | Incorrect Product Formulation: product did not contain insulin as listed in the label. | Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles / 1 bag | Class II | Ongoing |
| D-0264-2026 | 12-26-2025 | Benadryl, 25'S 2PK Box, UPC 815556020316 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0284-2026 | 12-26-2025 | LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0297-2026 | 12-26-2025 | parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 Package NDCs: 0135-0651-02; 0135-0651-03; 0135-0650-01 | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. | Haleon US Holdings LLC / 84,764 bottles | Class III | Ongoing |
| D-0270-2026 | 12-26-2025 | EXCEDRIN MIGRAINE 2'S- 25 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0279-2026 | 12-26-2025 | TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0271-2026 | 12-26-2025 | MOTRIN 2'S DISP.- 50CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0268-2026 | 12-26-2025 | LIQUID DAYQUIL 12/8oz | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0287-2026 | 12-26-2025 | Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0282-2026 | 12-26-2025 | Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0273-2026 | 12-26-2025 | NYQUIL COLD & FLU -32CT/2PK | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0272-2026 | 12-26-2025 | LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0265-2026 | 12-26-2025 | Bayer 2Pk- 25 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0275-2026 | 12-26-2025 | PEPTO BISMOL 32CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0286-2026 | 12-26-2025 | Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0283-2026 | 12-26-2025 | Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0276-2026 | 12-26-2025 | PEPCID COMPLETE - 25CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0261-2026 | 12-26-2025 | Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unkown | Class II | Ongoing |
| D-0262-2026 | 12-26-2025 | Aleve 1's, 60 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0281-2026 | 12-26-2025 | Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0269-2026 | 12-26-2025 | EXCEDRIN 2'S DISP.- 30 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0274-2026 | 12-26-2025 | CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0266-2026 | 12-26-2025 | Claritin, 20 Count, UPC: 655708016305 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0267-2026 | 12-26-2025 | DAYQUIL COLD & FLU, 32CT/2PK | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0263-2026 | 12-26-2025 | Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0277-2026 | 12-26-2025 | TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
