FDA Enforcement Database
Drug Safety & Recalls Center
Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.
Last Synchronized
5 hours ago
Total FDA Recalls
1,244
Active / Ongoing
1,207
Critical (Class I)
66
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.
Latest Critical Safety Updates (Class I)
Recent FDA enforcement reports involving serious health risk classifications
Class II (Moderate Risk)
Drug recall
Recall #: D-0063-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-519-35, Item # 88519, UPC 8 10147 88519 0
Lots / Batch Codes & Expiration Dates
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0065-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3
Lots / Batch Codes & Expiration Dates
Lot # LWP250032331302B, Exp Date: 02/23/2027; Lot # LWP250034892603, Exp Date: 04/07/2027; Lot # LWP250032581702, Exp Date: 04/14/2027; Lot # LWP250045162409, Exp Date: 10/17/2027; Lot # LWP250032331302A, LWP250047640511A, Exp Date: 12/20/2027; Lot # LWP250051162312B, Exp Date: 01/04/2028; Lot # LWP0054880903B, Exp Date: 04/08/2028; Lot # LWP...
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0055-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-003-40, Item # 32731, UPC 8 50048 32731 3
Lots / Batch Codes & Expiration Dates
Lot # LWP240027561211, Exp Date: 12/07/2026; Lot # LWP250031970602, Exp Date: 02/28/2027; Lot # LWP250031980602, Exp Date: 03/11/2027; Lot # LWP250032381402, Exp Date: 03/17/2027; Lot # LWP250035680204, Exp Date: 04/30/2027; Lot # LWP250037682005A, Exp Date: 06/08/2027; Lot # LWP250048601811, Exp Date: 12/09/2027; Lot # LWP250051382412, Exp...
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0051-2027
LEVOXYL
Manufacturer / Recalling Firm: Pfizer
Reason for Recall: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Affected Product Description
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
Lots / Batch Codes & Expiration Dates
Lot # 24W07, Exp: 11/30/2026
Distribution Scope
US Nationwide and Puerto Rico
Class II (Moderate Risk)
Drug recall
Recall #: D-0070-2027
Testosterone Cypionate
Manufacturer / Recalling Firm: Right Value Drug Stores LLC
Reason for Recall: Lack of sterility assurance.
Affected Product Description
Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office Use Only, 8400 Esters Blvd, STE 190, Irving, TX 75063.
Lots / Batch Codes & Expiration Dates
a) Lot 10212025@3, BUD 10/21/2026; 10292025@4, BUD 10/29/2026; 10282025@6, BUD: 10/29/2026; 12012025@1, BUD: 12/01/2026; 04072026@1, BUD: 04/01/2027; 05262026@3, BUD 05/08/2027; 05262026@7, BUD 11/17/2026; 05272026@1, BUD 05/08/2027; 05272026@2, BUD: 11/22/2026; 07032026@1, BUD 05/08/2027; 07022026@1, BUD: 05/08/2027; 07062026@3, BUD: 05/08/2027; 0...
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0053-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-001-40, Item# 88022, UPC 8 10147 88022 5
Lots / Batch Codes & Expiration Dates
Lot# LWP250031810502A, LWP250032571702A, Exp Date: 02/28/2027; Lot# LWP250035710304A, Exp Date: 04/27/2027; Lot # LWP250037812105, Exp Date: 06/03/2027; Lot # LWP250045750310, Exp Date: 02/19/2028; Lot # LWP260055421803, Exp Date: 05/13/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0061-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-517-35, Item # 88517, UPC 8 10147 88517 6
Lots / Batch Codes & Expiration Dates
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0069-2027
ARU
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Lots / Batch Codes & Expiration Dates
Lot # LWP250047850611C, Exp Date: 12/22/2027; Lot # LWP260052612201C, Exp Date: 3/31/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0045-2027
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Out of specification due to dissolution.
Affected Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
Lots / Batch Codes & Expiration Dates
Lot # 25120696, Exp Date: December 31, 2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0059-2027
evo
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19, Item# 88619, UPC 8 10147 88619 7
Lots / Batch Codes & Expiration Dates
Lot# LWP250038750606, Exp Date: 08/03/2027; Lot# LWP250045152409A, Exp Date: 10/06/2027; Lot# LWP250046862110A, Exp Date: 11/11/2027; Lot# LWP250047640511B, Exp Date: 12/17/2027; Lot# LWP250051172312A, Exp Date: 01/25/2028; Lot# LWP250051182312B, Exp Date: 01/28/2028; Lot# LWP260052241401B, Exp Date: 03/18/2028; Lot# LWP0054880903F, Exp Date...
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0052-2027
LEVOXYL
Manufacturer / Recalling Firm: Pfizer
Reason for Recall: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Affected Product Description
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.
Lots / Batch Codes & Expiration Dates
Lot # 24W06, Exp: 11/30/2026
Distribution Scope
US Nationwide and Puerto Rico
Class II (Moderate Risk)
Drug recall
Recall #: D-0064-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-518-35, Item # 88518, UPC 8 10147 88518 3
Lots / Batch Codes & Expiration Dates
Lot# LWP250037221405, Exp Date: 07/04/2027; Lot# LWP250048151011, Exp Date: 11/11/2027; Lot# LWP250051162312A, Exp Date: 02/08/2028; Lot# LWP0054880903C, Exp Date: 04/30/2028.
Distribution Scope
US Nationwide.
Class I (High Risk)
Drug recall
Recall #: D-0083-2027
ARGATROBAN
Manufacturer / Recalling Firm: Par Health USA, LLC
Reason for Recall: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Affected Product Description
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.
Lots / Batch Codes & Expiration Dates
Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027.
Distribution Scope
Nationwide within the United States
Class I (High Risk)
Drug recall
Recall #: D-0084-2027
Glutathione Injection
Manufacturer / Recalling Firm: Greenwich Rx
Reason for Recall: Microbial Contamination of Sterile Products
Affected Product Description
Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.
Lots / Batch Codes & Expiration Dates
Lot # 0060-062426-1, BUD: 10/02/2026; Lot # 0060-062726-1, BUD: 10/05/2026; Lot # 0060-070926-1, BUD: 10/17/2026; Lot # 0060-071426-1, BUD: 10/22/2026; Lot #0060-071426-2, BUD: 10/22/2026; Lot # 0060-072026-1, BUD: 10/28/2026; Lot # 0060-072726-1, BUD: 11/04/2026; Lot #0060-072926-1, BUD: 11/06/2026; Lot # 0060-073126-1; BUD: 11/08/2026; Lot # 0060...
Distribution Scope
US Nationwide in th USA
Class III (Low Risk)
Drug recall
Recall #: D-0049-2027
TELMISARTAN AND AMLODIPINE
Manufacturer / Recalling Firm: Viatris, Inc.
Reason for Recall: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Affected Product Description
Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.
Lots / Batch Codes & Expiration Dates
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0068-2027
ARU
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Lots / Batch Codes & Expiration Dates
Lot # LWP250047850611D, Exp Date: 12/23/2027; Lot # LWP260052612201D, Exp Date: 04/30/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0057-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-005-40, Item # 32732, UPC 8 50048 32732 0
Lots / Batch Codes & Expiration Dates
Lot # LWP240027561211, Exp Date: 12/07/2026; Lot # LWP250031970602, Exp Date: 02/28/2027; Lot # LWP250031980602, Exp Date: 03/11/2027; Lot # LWP250032381402, Exp Date: 03/17/2027; Lot # LWP250035680204, Exp Date: 04/30/2027; Lot # LWP250037682005A, Exp Date: 06/08/2027; Lot # LWP250048601811, Exp Date: 12/09/2027; Lot # LWP250051382412, Exp...
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0050-2027
HEPARIN SODIUM
Manufacturer / Recalling Firm: Shenzhen Techdow Pharmaceutical Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01
Lots / Batch Codes & Expiration Dates
Lot# CU03232A, Exp 1/31/2028
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0076-2027
ABIRTEGA
Manufacturer / Recalling Firm: Hikma Pharmaceuticals USA INC.
Reason for Recall: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Affected Product Description
Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.
Lots / Batch Codes & Expiration Dates
Lot #: 3047, Exp Date July 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0054-2027
Brush Buddies
Manufacturer / Recalling Firm: PRITAM INTERNATIONAL PRIVATE LIMITED
Reason for Recall: CGMP Deviations.
Affected Product Description
Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8
Lots / Batch Codes & Expiration Dates
Lot# LWP250031810502B, Exp Date: 02/26/2027; Lot# LWP250032571702B, Exp Date: 03/05/2027; Lot# LWP250035710304B, Exp Date: 04/17/2027; Lot# LWP260052231401, Exp Date: 02/17/2028; Lot# LWP0054880903A, Exp Date: 04/30/2028, Lot# LWP250035370104, Exp Date: 12/4/2028.
Distribution Scope
US Nationwide.