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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Ongoing Historical recordClass II

Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.

by Teva Pharmaceuticals USA, Inc

Reason: Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Recall initiated: June 28, 2024
Reported by FDA: July 24, 2024
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.

by Zydus Pharmaceuticals (USA) Inc

Reason: Presence of particulate matter: glass
Recall initiated: June 27, 2024
Reported by FDA: July 24, 2024
Distribution: TN

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Drug Recall Ongoing Historical recordClass II

Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.

by Brands International Corporation

Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Recall initiated: June 10, 2024
Reported by FDA: July 24, 2024
Distribution: USA nationwide.

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Drug Recall Terminated Historical recordClass II

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications
Recall initiated: July 9, 2024
Reported by FDA: July 24, 2024
Distribution: Nationwide in the USA and Puerto rico

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Drug Recall Ongoing Historical recordClass III

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

by Rising Pharma Holding, Inc.

Reason: Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Recall initiated: June 24, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA

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Drug Recall Completed Historical recordClass III

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).

by Zydus Pharmaceuticals (USA) Inc

Reason: Cross contamination with other products
Recall initiated: July 2, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Completed Historical recordClass III

Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).

by Zydus Pharmaceuticals (USA) Inc

Reason: Cross contamination with other products
Recall initiated: July 2, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2

by Tailstorm Health INC

Reason: Subpotent Drug: reduced efficacy for epinephrine
Recall initiated: July 3, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.

by Zydus Pharmaceuticals (USA) Inc

Reason: Cross contamination with other products.
Recall initiated: July 2, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,

by Zydus Pharmaceuticals (USA) Inc

Reason: Cross contamination with other products.
Recall initiated: July 2, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc

by Equibal Inc

Reason: CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Recall initiated: June 26, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA via internet sales.

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Drug Recall Ongoing Historical recordClass II

buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.

by Amerisource Health Services LLC

Reason: Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Recall initiated: June 24, 2024
Reported by FDA: July 17, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA

by SYNCHRONICITY SPA INC, DBA SUNTE

Reason: CGMP Deviations
Recall initiated: May 24, 2024
Reported by FDA: July 17, 2024
Distribution: Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan

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Drug Recall Ongoing Historical recordClass I

suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187

by SYNCHRONICITY SPA INC, DBA SUNTE

Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Recall initiated: May 24, 2024
Reported by FDA: July 17, 2024
Distribution: Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan

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Drug Recall Ongoing Historical recordClass II

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01

by Baxter Healthcare Corporation

Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Recall initiated: June 17, 2024
Reported by FDA: July 17, 2024
Distribution: US Nationwide, Canada

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Drug Recall Ongoing Historical recordClass I

To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

by Integrity Products

Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Recall initiated: February 1, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

by Integrity Products

Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Recall initiated: February 1, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Recall initiated: June 18, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide. No foreign consignees.

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Drug Recall Terminated Historical recordClass II

Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.

by Dr. Reddy's Laboratories, Inc.

Reason: Presence of foreign substance.
Recall initiated: June 7, 2024
Reported by FDA: July 10, 2024
Distribution: IL, MS, OH

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Drug Recall Ongoing Historical recordClass II

Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Recall initiated: July 2, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide in the USA

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Data last updated: October 31, 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. Read the full medical disclaimer.