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
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
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 I
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II (Moderate Risk)
Drug recall
Recall #: D-0567-2025
Duloxetine D/R
Manufacturer / Recalling Firm: Direct Rx
Reason for Recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Affected Product Description
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
Lots / Batch Codes & Expiration Dates
Lot #: 02AU2406, Exp 01/31/2027
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0564-2025
Semaglutide + Cyanocobalamin injection solution
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0563-2025
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0552-2025
DULOXETINE
Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Lots / Batch Codes & Expiration Dates
Lot: 230836C, Exp.: 02/28/2026
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0546-2025
CINACALCET
Manufacturer / Recalling Firm: Strides Pharma, Inc.
Reason for Recall: Failed Dissolution Specifications.
Affected Product Description
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04
Lots / Batch Codes & Expiration Dates
Lot #: 7715893A, Exp. Date 12/31/2027
Distribution Scope
Product was distributed nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0545-2025
BICILLIN L-A
Manufacturer / Recalling Firm: Pfizer Inc.
Reason for Recall: CGMP Deviations; particulates identified during visual inspection
Affected Product Description
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04
Lots / Batch Codes & Expiration Dates
Lots GT2598, GT2599, Exp 09/30/26; HK2909, Exp 02/28/27; HR9969, Exp 04/30/27; HR9984, Exp 08/31/27.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0551-2025
LORAZEPAM
Manufacturer / Recalling Firm: Hikma Pharmaceuticals USA Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Affected Product Description
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
Lots / Batch Codes & Expiration Dates
Lot # K24118, exp. date 10/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0544-2025
BICILLIN L-A
Manufacturer / Recalling Firm: Pfizer Inc.
Reason for Recall: CGMP Deviations; particulates identified during visual inspection
Affected Product Description
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02
Lots / Batch Codes & Expiration Dates
Lots: HJ3235, Exp 09/30/26; GL2954, HP6222, Exp, 01/31/27; HR9967, Exp 05/31/27; HP6232, LT5190,Exp 09/30/27; HP6228, Exp 10/31/27;
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0547-2025
Sucralfate Tablets
Manufacturer / Recalling Firm: Nostrum Laboratories, Inc.
Reason for Recall: 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 charac...
Affected Product Description
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
Lots / Batch Codes & Expiration Dates
All Lots within expiry dates.
Distribution Scope
nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0543-2025
TIMOLOL MALEATE
Manufacturer / Recalling Firm: FDC Limited
Reason for Recall: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Affected Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Lots / Batch Codes & Expiration Dates
Lot#: 083L061, Exp.: 11/2025.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0542-2025
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Affected Product Description
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
Lots / Batch Codes & Expiration Dates
Lot GB01616, expiration 2/28/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0538-2025
PROLIA
Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: CGMP Deviations; potential temperature excursions due to transit delays
Affected Product Description
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Lots / Batch Codes & Expiration Dates
Lot: 1180924, Expiration date: 6/30/2027.
Distribution Scope
Within the U.S - OH, VA, FL.
Class II (Moderate Risk)
Drug recall
Recall #: D-0540-2025
BENLYSTA
Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: CGMP Deviations; potential temperature excursions due to transit delays
Affected Product Description
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Lots / Batch Codes & Expiration Dates
Lot: YK4W, Expiration date: 4/30/2029
Distribution Scope
Within the U.S - OH, VA, FL.
Class II (Moderate Risk)
Drug recall
Recall #: D-0537-2025
CLOMIPRAMINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Affected Product Description
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lots / Batch Codes & Expiration Dates
Lot # M300464, exp. date June, 2025
Distribution Scope
Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0535-2025
Epinephrine Lidocaine HCL
Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Sub-Potent Drug: Subpotent assay results during stability testing.
Affected Product Description
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Lots / Batch Codes & Expiration Dates
Lot: 24DEC017, Exp. 07/12/2025.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0541-2025
BUDESONIDE
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Affected Product Description
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)
Lots / Batch Codes & Expiration Dates
Batch # 4IA0505, Exp 09/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0539-2025
EVENITY
Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: CGMP Deviations; potential temperature excursions due to transit delays
Affected Product Description
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Lots / Batch Codes & Expiration Dates
Lot: 1178382, Expiration date: 3/31/2027
Distribution Scope
Within the U.S - OH, VA, FL.
Class III (Low Risk)
Drug recall
Recall #: D-0536-2025
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Sub-Potent Drug: Subpotent assay results during stability testing.
Affected Product Description
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Lots / Batch Codes & Expiration Dates
Lot: 25MAR032, Exp. 07/16/2025.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0521-2025
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug: Assay below the approved specification
Affected Product Description
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
Lots / Batch Codes & Expiration Dates
Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0533-2025
RIZATRIPTAN BENZOATE
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Affected Product Description
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Lots / Batch Codes & Expiration Dates
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
Distribution Scope
US Nationwide.