Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,222 recalls
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
- Lots / codes
- Lot: AM240336, AM240337, Exp Date 02/28/2027.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 3,363 100-count bottles
- Recall started
- August 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0619-2025
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count 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 69238-1060-1.
- Lots / codes
- Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 14,923 100-count bottles
- Recall started
- August 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0618-2025
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC,…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count 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 69238-1058-1.
- Lots / codes
- Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 13,130 100-count bottles
- Recall started
- August 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0617-2025
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Class II Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
- Lots / codes
- Lot AM240617, AM240618, Exp Date 04/30/2027
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 7,228 100-count bottles
- Recall started
- August 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0616-2025
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Class II Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt…
Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots, distribution and details
- Product
- Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
- Lots / codes
- Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27.
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 60,072 100-count, 73,054 500-count bottles
- Recall started
- August 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0615-2025
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Class II Ongoing
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocor…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
- Lots / codes
- NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
- Distribution
- US Nationwide
- Quantity
- 7,572 vials
- Recall started
- June 10, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0614-2025
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Class I Ongoing
PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Lots, distribution and details
- Lots / codes
- Lot #: 31013A, Exp. Date 11/2025; 40345A, 40355A, Exp. Date 4/2026; 40571A, 40580A, Exp. Date 6/2026; 40587A, 40591A, Exp. Date 7/2026; 40870.1, 40877.1, Exp. Date 10/2026; 41093A, Exp. Date 12/2026; 50072A, 50079A, Exp. Date 1/2027
- Distribution
- Nationwide within the USA
- Quantity
- 5,703 bottles
- Recall started
- July 17, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0613-2025
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Class I Ongoing
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Lots, distribution and details
- Product
- KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
- Lots / codes
- Lot #: 30705A, Exp. Date 8/2025; 30771A, Exp. Date 9/2025; 30920A, Exp. Date 10/2025; 40016A, Exp. Date 1/2026; 40303A, Exp. Date 4/2026; 40428A, Exp. Date 5/2026; 40505A, Exp. Date 6/2026; 41053C, 41053A, 41053B, Exp. Date 12/2026, 50017A, Exp. Date 1/2027.
- Distribution
- Nationwide within the USA
- Quantity
- 6,973 cartridges
- Recall started
- July 17, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0612-2025
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Class I Ongoing
DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Lots, distribution and details
- Product
- DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- Lots / codes
- Lot #: 40187.2, Exp. Date 2/2026
- Distribution
- Nationwide within the USA
- Quantity
- 249 bottles
- Recall started
- July 17, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0611-2025
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Class I Ongoing
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Indu…
Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Lots, distribution and details
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. Date 12/2025; 40012A, Exp. Date 1/2026; 40301A, Exp. Date 3/2026; 40789 A, Exp. Date 9/2026; 50068B, Exp. Date 1/2027; 50144A, 50149A, Exp. Date 2/2027.
- Distribution
- Nationwide within the USA
- Quantity
- 11,321 bag in boxes
- Recall started
- July 17, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0610-2025
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Class II Ongoing
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 03202025@2, 03202025@3 and 03202025@4 BUD 07/18/2025
- Distribution
- U.S. Nationwide
- Quantity
- 648 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0609-2025
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Class II Ongoing
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 03202025@9 BUD 07/18/2025
- Distribution
- U.S. Nationwide
- Quantity
- 186 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0608-2025
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Class III Ongoing
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 06092025@23 BUD 09/09/2025
- Distribution
- U.S. Nationwide
- Quantity
- 8 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0607-2025
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Class II Ongoing
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 03202025@5, 03202025@6, 03202025@7, 03202025@8 BUD 07/18/2025
- Distribution
- U.S. Nationwide
- Quantity
- 642 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0606-2025
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Class II Ongoing
RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224070083
- Distribution
- Nationwide
- Quantity
- 984,000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0605-2025
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Class II Ongoing
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224070074
- Distribution
- Nationwide
- Quantity
- 66,000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0604-2025
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Class II Ongoing
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224080041
- Distribution
- Nationwide
- Quantity
- 300000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0603-2025
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Class II Ongoing
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Lots / codes
- 61224070073
- Distribution
- Nationwide
- Quantity
- 3,456,000 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0602-2025
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Class II Ongoing
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www…
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Product
- CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
- Lots / codes
- 61224050002
- Distribution
- Nationwide
- Quantity
- 1,639,996 pads
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0601-2025
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Class II Ongoing
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC…
Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Lots, distribution and details
- Product
- Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
- Lots / codes
- 61224040057
- Distribution
- Nationwide
- Quantity
- 6669874 swabs
- Recall started
- July 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0600-2025
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Class II Terminated
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Reason: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Lots, distribution and details
- Lots / codes
- Lot #: 25280726A, Exp. Date 03/2027
- Distribution
- Nationwide within the USA
- Quantity
- 8544 bottles
- Recall started
- August 11, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0599-2025
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Class II Ongoing
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10×10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 – Carton NDC [60687-695-11- Unit Dose]
Reason: CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Lots, distribution and details
- Lots / codes
- Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.
- Distribution
- Nationwide
- Quantity
- 26,992 blister packs
- Recall started
- July 29, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0598-2025
-
Class II Ongoing
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package – NDC 55154-3543-…
Reason: Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Lots, distribution and details
- Product
- Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package – NDC 55154-3543-5, Inner label – NDC 0781-3238-01
- Lots / codes
- Outer package – NDC 55154-3543-5, Lot SAD08033AA Inner label – NDC 0781-3238-01, Lot SAF13211A
- Distribution
- KS
- Quantity
- 10 bags
- Recall started
- August 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0597-2025
-
Class II Ongoing
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Reason: Discoloration
Lots, distribution and details
- Lots / codes
- Lot #: 24A27G66, Exp 12/31/2025
- Distribution
- U.S.A. Nationwide
- Quantity
- 13,000 containers
- Recall started
- August 20, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0596-2025
-
Class II Ongoing
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016.…
Reason: Discoloration
Lots, distribution and details
- Product
- Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
- Lots / codes
- Lot #: T401968
- Distribution
- Nationwide in the USA
- Quantity
- 3960 bottles
- Recall started
- August 12, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0595-2025
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 2, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.