Showing 421–440 of 18,047 drug recalls
Drug Recall
Ongoing
2026 record Class III
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08. by Premier Dental Products Co
Reason
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed. Recall initiated
April 14, 2026 Reported by FDA
April 29, 2026 Distribution
Nationwide within the United States
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Drug Recall
Ongoing
2026 record Class II
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. by Harrow Eye LLC
Reason
Lack of Assurance of Sterility Recall initiated
April 17, 2026 Reported by FDA
April 29, 2026 Distribution
Nationwide within the United States
View recall →
Drug Recall
Ongoing
2026 record Class II
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01 by Leading Pharma, LLC
Reason
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Recall initiated
March 20, 2026 Reported by FDA
April 29, 2026 Distribution
US Nationwide.
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Drug Recall
Ongoing
2026 record Class II
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10 by Hetero Labs Limited (Unit V)
Reason
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." Recall initiated
March 26, 2026 Reported by FDA
April 29, 2026 Distribution
Nationwide in the USA.
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Drug Recall
Ongoing
2026 record Class II
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06 by The Harvard Drug Group LLC
Reason
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. Recall initiated
April 9, 2026 Reported by FDA
April 29, 2026 Distribution
Nationwide in the USA
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
April 2, 2026 Reported by FDA
April 22, 2026 Distribution
USA Nationwide.
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
April 2, 2026 Reported by FDA
April 22, 2026 Distribution
USA Nationwide.
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
April 2, 2026 Reported by FDA
April 22, 2026 Distribution
USA Nationwide.
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
April 2, 2026 Reported by FDA
April 22, 2026 Distribution
USA Nationwide.
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Drug Recall
Ongoing
2026 record Class 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. Recall initiated
April 8, 2026 Reported by FDA
April 22, 2026 Distribution
U.S.A. Nationwide
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
March 31, 2026 Reported by FDA
April 22, 2026 Distribution
Nationwide in the USA, Belgium and France
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
April 1, 2026 Reported by FDA
April 22, 2026 Distribution
U.S. Nationwide
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
March 24, 2026 Reported by FDA
April 22, 2026 Distribution
US Nationwide.
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
April 1, 2026 Reported by FDA
April 22, 2026 Distribution
U.S. Nationwide
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Drug Recall
Terminated
2026 record Class 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 Recall initiated
March 18, 2026 Reported by FDA
April 22, 2026 Distribution
U.S. Nationwide
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Drug Recall
Terminated
2026 record Class 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 Recall initiated
March 18, 2026 Reported by FDA
April 22, 2026 Distribution
U.S. Nationwide
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Drug Recall
Terminated
2026 record Class 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 Recall initiated
March 18, 2026 Reported by FDA
April 22, 2026 Distribution
U.S. Nationwide
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Drug Recall
Ongoing
2026 record Class 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 Recall initiated
March 17, 2026 Reported by FDA
April 22, 2026 Distribution
Nationwide within the United States
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Drug Recall
Ongoing
2026 record Class 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. Recall initiated
March 25, 2026 Reported by FDA
April 22, 2026 Distribution
Nationwide in the USA.
View recall →
Drug Recall
Ongoing
2026 record Class 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. Recall initiated
March 25, 2026 Reported by FDA
April 22, 2026 Distribution
Nationwide in the USA.
View recall →
Data last updated: October 30, 2026 ET
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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