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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 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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Drug Recall Ongoing Historical recordClass III

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Impurities/Degradation Specifications: Related Substances
Recall initiated: June 4, 2024
Reported by FDA: July 10, 2024
Distribution: OH, MS

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Drug Recall Terminated Historical recordClass III

Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308

by ACCORD HEALTHCARE, INC.

Reason: Subpotent drug: out of specification results
Recall initiated: June 18, 2024
Reported by FDA: July 10, 2024
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass II

Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

by Trigen Laboratories

Reason: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Recall initiated: June 17, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason: CGMP deviations
Recall initiated: June 20, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide USA and Ontario, Canada (2 retailers)

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Data last updated: September 8, 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.