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
8 hours ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
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-0748-2026
SEMAGLUTIDE 2.25MG
Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Affected Product Description
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
Lots / Batch Codes & Expiration Dates
Lot: AC-017114, Exp. 11/24/2026; AC-017164, AC-017204, AC-017205, Exp. 12/31/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0747-2026
SEMAGLUTIDE 12.5MG
Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Affected Product Description
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
Lots / Batch Codes & Expiration Dates
Lot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-017224, AC-017225, Exp. 12/31/2026
Distribution Scope
Nationwide within the U.S
Class I (High Risk)
Drug recall
Recall #: D-0772-2026
Glutathione
Manufacturer / Recalling Firm: Victory Medical Center Pharmacy
Reason for Recall: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Affected Product Description
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
Lots / Batch Codes & Expiration Dates
Lot # 1984345, 1980571, 1981940, Use Before Date: 08/27/2026.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0755-2026
SEMAGLUTIDE 7.5mg
Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Affected Product Description
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
Lots / Batch Codes & Expiration Dates
Lot: AC-017273, Exp. 12/12/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0759-2026
SILDENAFIL CITRATE USP
Manufacturer / Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall: CGMP Deviations:Noted during FDA inspection
Affected Product Description
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
Lots / Batch Codes & Expiration Dates
Batch SDC2505001, Date of Expiry: April 30, 2030.
Distribution Scope
Distributed Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0769-2026
Kian Pee Wan Capsules
Manufacturer / Recalling Firm: Buy-Herbal
Reason for Recall: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Affected Product Description
Kian Pee Wan Capsules, 30-count bottles
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
Product was sold to individual consumers via ebay third party seller.
Class I (High Risk)
Drug recall
Recall #: D-0743-2026
Cyclophosphamide for Injection
Manufacturer / Recalling Firm: Sunny Pharmtech Inc.
Reason for Recall: Presence of Particulate Matter; identified as stainless steel
Affected Product Description
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Lots / Batch Codes & Expiration Dates
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0745-2026
MIRABEGRON
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Affected Product Description
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
Lots / Batch Codes & Expiration Dates
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall
Recall #: D-0740-2026
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Manufacturer / Recalling Firm: Central Admixture Pharmacy Services Inc
Reason for Recall: Incorrect Product Formulation
Affected Product Description
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418
Lots / Batch Codes & Expiration Dates
Lot #: 20-1535990-0-1 & 20-1535892-0-1, Exp. Date 16 July 2026
Distribution Scope
GA only
Class I (High Risk)
Drug recall
Recall #: D-0744-2026
Cyclophosphamide for Injection
Manufacturer / Recalling Firm: Sunny Pharmtech Inc.
Reason for Recall: Presence of Particulate Matter; identified as stainless steel
Affected Product Description
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Lots / Batch Codes & Expiration Dates
Lot # V24010V1, Exp 3/31/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0733-2026
DICYCLOMINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Aurobindo Pharma USA Inc
Reason for Recall: shortfill; reports of empty capsules.
Affected Product Description
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Lots / Batch Codes & Expiration Dates
Batch # DMC125018A, Exp Date: 07/2027.
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0737-2026
DABIGATRAN ETEXILATE
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Affected Product Description
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
Lots / Batch Codes & Expiration Dates
Lot: 25141583, Exp. April 30, 2027.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0730-2026
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION
Manufacturer / Recalling Firm: MICRO LABS USA INC
Reason for Recall: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Affected Product Description
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.
Lots / Batch Codes & Expiration Dates
Lot # DLHU0031, Exp Date: 06/30/2027.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0734-2026
MYCOPHENOLATE MOFETIL
Manufacturer / Recalling Firm: MYLAN PHARMACEUTICALS INC
Reason for Recall: Presence of precipitate
Affected Product Description
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).
Lots / Batch Codes & Expiration Dates
Lot #: 3241653, Exp 4/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0731-2026
AZELAIC ACID
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Affected Product Description
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Lots / Batch Codes & Expiration Dates
Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Distribution Scope
Nationwide within the United States.
Class III (Low Risk)
Drug recall
Recall #: D-0739-2026
DABIGATRAN ETEXILATE
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Affected Product Description
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
Lots / Batch Codes & Expiration Dates
Lot: 25141586, Exp. April 30, 2027.
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall
Recall #: D-0738-2026
DABIGATRAN ETEXILATE
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Affected Product Description
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Lots / Batch Codes & Expiration Dates
Lot: 25141585, Exp. April 30, 2027.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0721-2026
ROHTO DRY-AID
Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
Lots / Batch Codes & Expiration Dates
Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06; 512V, 512VB 2028/08
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0706-2026
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
Affected Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61
Lots / Batch Codes & Expiration Dates
Lot #: N02167, Exp. Date 07/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0715-2026
ROHTO
Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1
Lots / Batch Codes & Expiration Dates
Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10; 4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/0...
Distribution Scope
Nationwide within the United States