Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: Jan 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276118, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1276119, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Guardian Drug Co. Inc.: TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129…
Presence of foreign substance: small metallic particles in chewable tablets.
Product, lots & distribution
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 1716089, expires: JAN- 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
Ajanta Pharma USA Inc: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120…
CGMP Deviations
Product, lots & distribution
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. — Distribution: U.S. Nationwide — Lots/codes: Lot # PA02216; Exp. 12/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, T…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 329… — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 21…
Non-Sterility: Due to presence of Aspergillus penicillioides.
Product, lots & distribution
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 4032183, Exp 01/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMay 28, 2026
CareFusion 213, LLC: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El…
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product, lots & distribution
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. — Distribution: Nationwide inthe USA, as well as other foreign distribution. — Lots/codes: Lot # 4073005, Exp 03/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Lannett Company Inc.: Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Product, lots & distribution
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 25282724A, Exp. Date 2027/01 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Glenmark Pharmaceuticals Inc., USA: Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day re…
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Product, lots & distribution
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 — Distribution: USA Nationwide. — Lots/codes: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 27, 2026
Ajanta Pharma USA Inc: Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Product, lots & distribution
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. — Distribution: U.S. Nationwide — Lots/codes: Lot: PA00805, expires: 01/31/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 22, 2026
Zep Inc: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, N…
Microbial contamination of sterile products
Product, lots & distribution
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85. — Distribution: US Nationwide. — Lots/codes: Batch # E2612116, Exp Date: April 2029. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:…
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Product, lots & distribution
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10 — Distribution: Nationwide within the United States — Lots/codes: Lot #: AD93852, Exp Date: 06/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 22, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by:…
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Product, lots & distribution
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10 — Distribution: Nationwide within the United States — Lots/codes: Lot #: AE11393, Exp Date: 10/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-000…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001917, Exp 04/01/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Fran…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001917, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, EXP 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 21, 2026
Keystone Industries: safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA,…
Defective container:may contain bottles with incomplete seals
Product, lots & distribution
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. — Distribution: Nationwide in the USA — Lots/codes: BNZ-001921, Exp 04/15/2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 19, 2026
Shimoga Chemicals: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, S…
cGMP deviations
Product, lots & distribution
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India. — Distribution: CA & FL only — Lots/codes: Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029. — 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 IIMedicationMay 18, 2026
IntegraDose Compounding Services LLC: Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
Subpotent Drug
Product, lots & distribution
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. — Distribution: U.S.A. Nationwide — Lots/codes: Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 18, 2026
PReye LLC: PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lack of Assurance of Sterility
Product, lots & distribution
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO — Distribution: CO — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AE001, expires: 5/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AE001, expires: 5/31/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AE006, expires: 5/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 15, 2026
PAI Holdings LLC: VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL…
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Product, lots & distribution
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08. — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: AH001, expires: 8/31/2026 — 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 IIMedicationMay 14, 2026
Asclemed USA Inc.: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Product, lots & distribution
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. — Distribution: US Nationwide. — Lots/codes: Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026 — 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 IIMedicationMay 12, 2026
ANI Pharmaceuticals, Inc.: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Defective Container; packets were found to be either empty or partially full.
Product, lots & distribution
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 — Distribution: Nationwide in the USA — Lots/codes: Lot M251109, exp Nov 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 12, 2026
IntegraDose Compounding Services LLC: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, M…
Subpotent Drug
Product, lots & distribution
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. — Distribution: Nationwide. — Lots/codes: Lot#: 20260310FEN-1, Exp. Date: 09/06/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 12, 2026
Spectra Medical Devices, Llc: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Lack of Assurance of Sterility
Product, lots & distribution
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. — Distribution: USA Nationwide — Lots/codes: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IMedicationMay 12, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,…
Presence of Particulate matter: Particulate matter identified as glass.
Product, lots & distribution
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. — Distribution: U.S. Nationwide — Lots/codes: Lot HAG2581B, expires: 05/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 11, 2026
Haleon US Holdings LLC: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Product, lots & distribution
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. — Distribution: U.S. Nationwide. — Lots/codes: Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 8, 2026
UCB Biosciences Inc.: cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, ND…
Lack of Assurance of Sterility
Product, lots & distribution
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81. — Distribution: US Nationwide. — Lots/codes: Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-22; CWNDS, Exp.: 2026-DEC-11. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMay 5, 2026
Ascend Laboratories, LLC: Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC.,…
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Product, lots & distribution
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30. — Distribution: U.S.A. Nationwide — Lots/codes: Lot: 24123460, Expires: October 31, 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)