Class III · Posted September 9, 2026 · Started August 31, 2026 · Ongoing
Trokendi XR
- Product
- Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
- Firm
- Supernus Pharmaceuticals, Inc., Rockville, MD
- Reason
- Failed dissolution specifications.
- Lots
- Lot# 2145283, Exp Date: 31-Mar-2030.
- Quantity
- 11304 bottles
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0833-2026
Class II · Posted September 9, 2026 · Started August 26, 2026 · Ongoing
mycophenolate mofetil
- Product
- Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
- Firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Reason
- Failed Dissolution Specifications
- Lots
- Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Quantity
- 11,336 units
- Distribution
- U.S. Nationwide
- RxNorm
- mycophenolate mofetil (RxCUI 311881)
- Recall number
- D-0830-2026
Class II · Posted September 9, 2026 · Started August 24, 2026 · Ongoing
trazodone hydrochloride
- Product
- traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- Presence of Foreign Tablets/Capsules
- Lots
- Lot: 1394026, Exp. 02/2028.
- Quantity
- 175,392 bottles
- Distribution
- U.S. Nationwide
- RxNorm
- trazodone hydrochloride (RxCUI 856364, 856373, 856377)
- Recall number
- D-0834-2026
Class II · Posted September 9, 2026 · Started August 21, 2026 · Ongoing
prasugrel
- Product
- Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
- Firm
- Golden State Medical Supply Inc., Camarillo, CA
- Reason
- Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
- Lots
- Lot # GS062298, Exp Date: 09/30/ 2026.
- Quantity
- 6791 30-count bottles
- Distribution
- US Nationwide.
- RxNorm
- prasugrel (RxCUI 855812, 855818)
- Recall number
- D-0847-2026
Class II · Posted September 9, 2026 · Started August 21, 2026 · Ongoing
Broadway Joe's Pain Cream
- Product
- Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
- Firm
- Lexia LLC, Franklin, TN
- Reason
- CGMP Deviations: Potential contamination of raw material
- Lots
- Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
- Quantity
- 1,200 4 oz-Jar
- Distribution
- Distributed in the state of Colorado (US).
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0829-2026
Class II · Posted September 9, 2026 · Started August 21, 2026 · Ongoing
Broadway Joe's Pain Cream
- Product
- Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
- Firm
- Lexia LLC, Franklin, TN
- Reason
- CGMP Deviations: Potential contamination of raw material
- Lots
- Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
- Quantity
- 2,400 2 oz-jars
- Distribution
- Distributed in the state of Colorado (US).
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0828-2026
Class III · Posted September 9, 2026 · Started August 19, 2026 · Ongoing
buprenorphine
- Product
- Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
- Firm
- American Health Packaging, Columbus, OH
- Reason
- Labeling: Label Mix-up
- Lots
- Lot # 1030023, Exp Date: 06/30/2027.
- Quantity
- 10,953 cartons.
- Distribution
- US Nationwide.
- RxNorm
- buprenorphine (RxCUI 351264, 351265)
- Recall number
- D-0840-2026
Class III · Posted September 9, 2026 · Started August 19, 2026 · Ongoing
elapegademase-lvlr
- Product
- Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
- Firm
- Chiesi USA, Inc., Cary, NC
- Reason
- Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
- Lots
- Lot#: 1221973, Exp 3/24/2027
- Quantity
- 3,002 vials
- Distribution
- MO, TN
- RxNorm
- elapegademase-lvlr (RxCUI 2059223, 2059228)
- Recall number
- D-0838-2026
Class II · Posted September 9, 2026 · Started August 18, 2026 · Ongoing
chlorhexidine gluconate
- Product
- 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
- Firm
- Sage Products, LLC, Cary, IL
- Reason
- Cross Contamination with Other Products
- Lots
- Lot 108491 with case sequence numbers 14841 through 20013.
- Quantity
- 165,536 packages
- Distribution
- US Nationwide.
- RxNorm
- chlorhexidine gluconate (RxCUI 846127)
- Recall number
- D-0837-2026
Class I · Posted September 9, 2026 · Started August 17, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- Presence of particulate matter: Particulates identified as fiberglass
- Lots
- Lot: Y495523, Y495523A, Exp 31-Oct-2027
- Quantity
- 145,464 500mL bags
- Distribution
- Natonwide in the USA
- RxNorm
- sodium chloride (RxCUI 1807551, 1807552, 1807627, 1807630, 1807631, +4 more)
- Recall number
- D-0849-2026
Class II · Posted September 9, 2026 · Started August 17, 2026 · Ongoing
prasugrel
- Product
- Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
- Firm
- Mylan Pharmaceuticals Inc, Morgantown, WV
- Reason
- Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
- Lots
- Lot #: 3225272, Exp. September 30, 2026
- Quantity
- 47,662 bottles
- Distribution
- Nationwide within the U.S
- RxNorm
- prasugrel (RxCUI 855812, 855818)
- Recall number
- D-0839-2026
Class II · Posted September 9, 2026 · Started August 14, 2026 · Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
- Firm
- Allies Group Inc., Wilmington, DE
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Lots
- Lots: G23W03B, Exp. 8/4/2027; A16X02, Exp. 1/20/2029: A16X03, Exp. 1/22/2029.
- Quantity
- 2,149 90mL-Tubes
- Distribution
- Nationwide within the U.S.A
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0826-2026
Class II · Posted September 9, 2026 · Started August 14, 2026 · Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
- Firm
- Allies Group Inc., Wilmington, DE
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Lots
- Lots: H22V02A, Exp. 8/30/2026; C13W01B, Exp. 3/27/2027; C24W01, Exp. 4/28/2027; G23W02, Exp. 7/25/2027; G23W01B, Exp. 7/24/2027; K10W02, Exp. 10/21/2028.
- Quantity
- 23,941, 20mL-Tube
- Distribution
- Nationwide within the U.S.A
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0825-2026
Class II · Posted September 9, 2026 · Started August 14, 2026 · Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
- Firm
- Allies Group Inc., Wilmington, DE
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Lots
- Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
- Quantity
- 27,492 3mL Sachets
- Distribution
- Nationwide within the U.S.A
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0824-2026
Class II · Posted September 9, 2026 · Started August 14, 2026 · Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
- Firm
- Allies Group Inc., Wilmington, DE
- Reason
- Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Lots
- Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.
- Quantity
- 29,014 50mL Tubes
- Distribution
- Nationwide within the U.S.A
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0823-2026
Class III · Posted September 9, 2026 · Started August 7, 2026 · Ongoing
doxylamine succinate and pyridoxine hydrochloride
- Product
- Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
- Firm
- Bionpharma Inc., Princeton, NJ
- Reason
- Presence of Foreign Tablets/Capsules
- Lots
- Lot # DMA25006, Exp Date: 11/30/2028.
- Quantity
- 14,232 bottles (1,423,200 tablets)
- Distribution
- US Nationwide.
- RxNorm
- doxylamine succinate and pyridoxine hydrochloride (RxCUI 1375948)
- Recall number
- D-0822-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
Daptomycin
- Product
- Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC193856, Exp Date: 04/18/2028.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0821-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
vancomycin hydrochloride
- Product
- Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC193894, Exp Date: 04/25/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- vancomycin hydrochloride (RxCUI 1807508, 1807510, 1807511, 2118448, 2387078)
- Recall number
- D-0820-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
vasopressin in 0.9% sodium chloride
- Product
- Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC185448, Exp Date: 8/31/2027; Lot # NC192910, Exp Date: 4/30/2028; Lot # NC195218, Exp Date: 6/30/2028.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- vasopressin in 0.9% sodium chloride (RxCUI 2399907, 2591428)
- Recall number
- D-0819-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
clindamycin phosphate
- Product
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC194068, Exp Date: 10/29/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- clindamycin phosphate (RxCUI 309335, 309336)
- Recall number
- D-0818-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
clindamycin phosphate
- Product
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC194075, Exp Date: 10/29/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- clindamycin phosphate (RxCUI 309335, 309336)
- Recall number
- D-0817-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
clindamycin phosphate
- Product
- Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC193689, Exp Date: 10/16/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- clindamycin phosphate (RxCUI 309335, 309336, 309339)
- Recall number
- D-0816-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
clindamycin phosphate
- Product
- Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- clindamycin phosphate (RxCUI 309335, 309336, 309339)
- Recall number
- D-0815-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
amiodarone hydrochloride
- Product
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- amiodarone hydrochloride (RxCUI 849876, 1046406, 1046408, 1046410)
- Recall number
- D-0814-2026
Class II · Posted September 9, 2026 · Started August 6, 2026 · Ongoing
nicardipine hydrochloride
- Product
- CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
- Firm
- Baxter Healthcare Corporation, Deerfield, IL
- Reason
- CGMP Deviations
- Lots
- Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- RxNorm
- nicardipine hydrochloride (RxCUI 858599, 858601, 858603, 858605)
- Recall number
- D-0813-2026