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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 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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Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; 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 Completed Historical recordClass II

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

by Medisca Inc.

Reason: CGMP Deviations and Presence of Particulate Matter: Glass
Recall initiated: June 26, 2024
Reported by FDA: July 10, 2024
Distribution: Nationwide in the USA and Canada

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Drug Recall Ongoing Historical recordClass III

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

by Neilmed Pharmaceuticals Inc

Reason: Sub-potent Drug
Recall initiated: June 24, 2024
Reported by FDA: July 3, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

by Golden State Medical Supply Inc.

Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Recall initiated: May 13, 2024
Reported by FDA: July 3, 2024
Distribution: Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass II

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01

by PACIRA PHARMACEUTICALS INC

Reason: Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Recall initiated: June 12, 2024
Reported by FDA: July 3, 2024
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606

by Contract Pharmacal Corporation

Reason: Discoloration: Brownish tablets
Recall initiated: May 20, 2024
Reported by FDA: July 3, 2024
Distribution: MI

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Drug Recall Ongoing Historical recordClass II

Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24

by Pfizer Inc.

Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recall initiated: May 20, 2024
Reported by FDA: July 3, 2024
Distribution: US Nationwide and Puerto Rico.

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Drug Recall Ongoing Historical recordClass II

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03

by Pfizer Inc.

Reason: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recall initiated: May 20, 2024
Reported by FDA: July 3, 2024
Distribution: US Nationwide and Puerto Rico.

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Drug Recall Completed Historical recordClass II

Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason: Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Recall initiated: April 24, 2024
Reported by FDA: July 3, 2024
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90

by Breckenridge Pharmaceutical, Inc

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated: May 17, 2024
Reported by FDA: June 26, 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.