FDA Recall
Ongoing
2026 recordClass II
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)
by Huons Co., Ltd.
- Reason
- Lack of Assurance of Sterility
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Huons Co., Ltd.
- Reason
- Lack of Assurance of Sterility
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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)
by Huons Co., Ltd.
- Reason
- Lack of Assurance of Sterility
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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)
by Huons Co., Ltd.
- Reason
- Lack of Assurance of Sterility
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
by Apotex Corp.
- Reason
- Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
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
by Avantor Performance Materials LLC
- Reason
- Subpotent drug
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
by Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Reason
- Failed Stability Specifications
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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
by The Harvard Drug Group LLC
- Reason
- Failed Dissolution Specifications
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
by International Medication Systems Ltd.
- Reason
- Lack of Assurance of Sterility
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
2026 recordClass III
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
by Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Reason
- Subpotent Drug
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
2026 recordClass III
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
by Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Reason
- Subpotent Drug
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
2026 recordClass III
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
by Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Reason
- Subpotent Drug
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
by Nephron SC, LLC
- Reason
- Labelling: Illegible label
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Fluocinonide, USP, 0.05% Cream, 60g 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 51672-1386-3.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Fluocinonide, USP, 0.05% Cream, 15g 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 51672-1386-1
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
- Reason
- 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.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
- Reason
- 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.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
- Reason
- 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.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
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.
by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
- Reason
- 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.
- Published
- April 22, 2026
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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