Class IIIMedicationJun 3, 2026
Amneal Pharmaceuticals, LLC: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distri…
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 — Distribution: Nationwide within the USA. — Lots/codes: Lot AM251676, EXP 11/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationJun 2, 2026
ANI Pharmaceuticals, Inc.: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Presence of foreign substance
Product, lots & distribution
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 — Distribution: Nationwide in the USA — Lots/codes: Lot S25133A — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationJun 1, 2026
Sandoz Inc: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Labeling: Incorrect or Missing Lot and/or Exp Date
Product, lots & distribution
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 — Distribution: U.S. Nationwide — Lots/codes: Lot VA0099422; Exp. Date June 30, 2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationJun 1, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-56…
Failed Impurities/Degradation Specifications
Product, lots & distribution
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 — Distribution: U.S. Nationwide — Lots/codes: Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 18, 2026
AbbVie Inc.: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-1…
Failed Stability Specifications
Product, lots & distribution
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. — Distribution: US Nationwide. — Lots/codes: Lot # 402805, 407596, Exp Date: 08/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 18, 2026
Eugia US LLC: Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Product, lots & distribution
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 — Distribution: US Nationwide. — Lots/codes: Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 14, 2026
AVEVA Drug Delivery Systems, Inc.: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0…
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Product, lots & distribution
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 56841, Expires: 03/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 14, 2026
Fresenius Kabi USA, LLC: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Failed Impurities/Degradations Specifications
Product, lots & distribution
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) — Distribution: US Nationwide. — Lots/codes: Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 4, 2026
Sagent Pharmaceuticals: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Failed Impurities/Degradation Specifications
Product, lots & distribution
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 1, 2026
Amerisource Health Services LLC: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton N…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 — Distribution: USA Nationwide — Lots/codes: Lot#: 1027583, Exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 1, 2026
Amerisource Health Services LLC: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton ND…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 — Distribution: USA Nationwide — Lots/codes: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 27, 2026
Golden State Medical Supply Inc.: Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 — Distribution: USA Nationwide — Lots/codes: Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 27, 2026
Golden State Medical Supply Inc.: Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-63…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 — Distribution: USA Nationwide — Lots/codes: Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 24, 2026
Lannett Company Inc.: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. — Distribution: USA Nationwide — Lots/codes: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 16, 2026
American Regent, Inc.: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Labeling: Missing Label
Product, lots & distribution
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 — Distribution: U.S. Nationwide — Lots/codes: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 14, 2026
Premier Dental Products Co: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-…
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Product, lots & distribution
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 640911253, Exp Date. 09/14/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 13, 2026
Unichem Pharmaceuticals USA Inc.: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India M…
Subpotent drug
Product, lots & distribution
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05. — Distribution: USA Nationwide — Lots/codes: Lot: ZBUL25001, Exp 12/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 7, 2026
Water-Jel Technologies, LLC: Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, R…
Failed PH Specifications
Product, lots & distribution
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950 — Distribution: Nationwide in the USA — Lots/codes: Lots: A5014, A5018, A5019 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMar 31, 2026
Avantor Performance Materials LLC: Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite…
Subpotent drug
Product, lots & distribution
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1 — Distribution: Nationwide in the USA, Belgium and France — Lots/codes: Lot 23G3161005, Exp 9/21/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Subpotent Drug
Product, lots & distribution
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13 — Distribution: U.S. Nationwide — Lots/codes: Lot 4155D2, 4155D3; Exp. 05/15/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Air…
Subpotent Drug
Product, lots & distribution
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04 — Distribution: U.S. Nationwide — Lots/codes: Lot 4212D2; Exp. 07/03/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.…
Subpotent Drug
Product, lots & distribution
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05 — Distribution: U.S. Nationwide — Lots/codes: Lot 4212D4; Exp. 07/31/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationFeb 19, 2026
Radnostix: Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 8340…
Failed Tablet/Capsule Specifications
Product, lots & distribution
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Distribution: Nationwide in the US, including Puerto Rico — Lots/codes: Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationFeb 18, 2026
Cipla USA, Inc.: 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, Su…
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Product, lots & distribution
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 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationFeb 18, 2026
Cipla USA, Inc.: Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 cap…
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Product, lots & distribution
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0223, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationFeb 12, 2026
Slate Run Pharmaceuticals: 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…
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.
Product, lots & distribution
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 — Distribution: Nationwide within the USA. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationFeb 3, 2026
Annora Pharma Private Limited: Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Seng…
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Product, lots & distribution
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. — Distribution: TN — Lots/codes: Lot #: A252487, Exp 05/31/2027 — Status: Ongoing (voluntary: firm initiated)