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-0471-2026
Semaglutide-Glycine-Cyanocobalamin Injectable
Manufacturer / Recalling Firm: PAYLESS COMPOUNDERS, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Lots / Batch Codes & Expiration Dates
Lot Number 01-27-2026@14S.5
Distribution Scope
OR
Class III (Low Risk)
Drug recall
Recall #: D-0480-2026
Remedy Gel
Manufacturer / Recalling Firm: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Reason for Recall: Subpotent Drug
Affected Product Description
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Lots / Batch Codes & Expiration Dates
Lot 4155D2, 4155D3; Exp. 05/15/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0456-2026
HONEY LEMON FLAVOR COUGH DROP
Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Affected Product Description
exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0460-2026
DISCOUNT DRUG MART
Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Affected Product Description
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0461-2026
MGC HEALTH
Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Affected Product Description
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085
Lots / Batch Codes & Expiration Dates
Lot# 20240524, Exp Date: 05/24/2026; Lot# 20240720, Exp Date: 07/20/2026; Lot# 20240730, Exp Date: 07/30/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0452-2026
FHF Farmhouse Fresh
Manufacturer / Recalling Firm: Owen Biosciences Inc.
Reason for Recall: Chemical contamination: Presence of benzene
Affected Product Description
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
Lots / Batch Codes & Expiration Dates
Lot #2595500, Exp.10/2/2026 Lot #2549700, Exp.6/12/2026 Lot #2638200, Exp.4/30/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0462-2026
MGC HEALTH
Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Affected Product Description
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.
Lots / Batch Codes & Expiration Dates
Lot# 20240524, Exp Date: 05/24/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0476-2026
FLUOCINONIDE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Affected Product Description
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Lots / Batch Codes & Expiration Dates
Lot# AD76251, Exp Date: 6/30/2026.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0422-2026
LANREOTIDE ACETATE
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Affected Product Description
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1,...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0434-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
Lots / Batch Codes & Expiration Dates
Batch# 24EU10010, Exp Date: 05/31/2027.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0445-2026
ISOTRETINOIN
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Superpotent and Subpotent
Affected Product Description
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Lots / Batch Codes & Expiration Dates
Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
Distribution Scope
FL, OH, PR & MS
Class II (Moderate Risk)
Drug recall
Recall #: D-0447-2026
OMNIPAQUE
Manufacturer / Recalling Firm: GE Healthcare Ireland Limited
Reason for Recall: Presence of particulate matter
Affected Product Description
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Lots / Batch Codes & Expiration Dates
Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; E...
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0442-2026
Vancomycin HCL
Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Product Description
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Lots / Batch Codes & Expiration Dates
Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.
Distribution Scope
Nationwide in the U.S.A.
Class II (Moderate Risk)
Drug recall
Recall #: D-0446-2026
ISOTRETINOIN
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Superpotent and Subpotent
Affected Product Description
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Lots / Batch Codes & Expiration Dates
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Distribution Scope
FL, OH, PR & MS
Class II (Moderate Risk)
Drug recall
Recall #: D-0431-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
Lots / Batch Codes & Expiration Dates
Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0429-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
Lots / Batch Codes & Expiration Dates
Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0425-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Lots / Batch Codes & Expiration Dates
Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0438-2026
norepinephrine Bitartrate
Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Product Description
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Lots / Batch Codes & Expiration Dates
Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/20...
Distribution Scope
Nationwide in the U.S.A.
Class II (Moderate Risk)
Drug recall
Recall #: D-0443-2026
ARTIFICIAL TEARS
Manufacturer / Recalling Firm: Preferred Pharmaceuticals, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Lots / Batch Codes & Expiration Dates
Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0444-2026
XANAX
Manufacturer / Recalling Firm: Viatris, Inc.
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Lots / Batch Codes & Expiration Dates
Lot# 8177156, Exp Date: 02/28/2027
Distribution Scope
US Nationwide.