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
1 hour 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-0465-2026
QUALITY CHOICE
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
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Lots / Batch Codes & Expiration Dates
Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0532-2026
LIDOCAINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0463-2026
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, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.
Lots / Batch Codes & Expiration Dates
Lot# 20240730, Exp Date: 07/30/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0487-2026
Blemish Spot Treatment
Manufacturer / Recalling Firm: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Reason for Recall: Failed Stability Specifications
Affected Product Description
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Lots / Batch Codes & Expiration Dates
Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0453-2026
HydroPeptide CLEAR ALLIANCE SERUM
Manufacturer / Recalling Firm: Owen Biosciences Inc.
Reason for Recall: Chemical contamination: Presence of benzene
Affected Product Description
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
Lots / Batch Codes & Expiration Dates
Lot# 2518800, Exp.: 4/30/2027 Lot# 2518900, Exp.: 4/1/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0469-2026
QUALITY CHOICE
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
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0529-2026
LIDOCAINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0488-2026
Magnesium Chloride
Manufacturer / Recalling Firm: Avantor Performance Materials LLC
Reason for Recall: Subpotent drug
Affected Product Description
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Lots / Batch Codes & Expiration Dates
Lot 23G3161005, Exp 9/21/2027
Distribution Scope
Nationwide in the USA, Belgium and France
Class II (Moderate Risk)
Drug recall
Recall #: D-0530-2026
BUPIVACAINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0450-2026
CINACALCET
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Affected Product Description
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall
Recall #: D-0481-2026
Skin Rehab
Manufacturer / Recalling Firm: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Reason for Recall: Subpotent Drug
Affected Product Description
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Lots / Batch Codes & Expiration Dates
Lot 4212D2; Exp. 07/03/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0531-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0458-2026
CARING MILL COUGH DROPS CHERRY
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
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0455-2026
SLMD Benzoyl Peroxide Acne Lotion
Manufacturer / Recalling Firm: Owen Biosciences Inc.
Reason for Recall: Chemical contamination: Presence of benzene
Affected Product Description
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Lots / Batch Codes & Expiration Dates
Lot# 2691700, Exp.10/31/2027 Lot# 2691800, Exp. 11/4/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0470-2026
QUALITY CHOICE COUGH DROPS VANILLA HONEY
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
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0457-2026
MENTHOL 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, Cough Drops, Menthol Flavor, 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: 83698-581-30, UPC: 614299398887.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0467-2026
QUALITY CHOICE COUGH DROPS CREAMY STRAWBERRY
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
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0464-2026
QUALITY CHOICE
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
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Lots / Batch Codes & Expiration Dates
Lot# 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0485-2026
MEMANTINE HYDROCHLORIDE
Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Lots / Batch Codes & Expiration Dates
Lot # N02425, Exp Date: 05/31/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0468-2026
QUALITY CHOICE
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
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.