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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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Showing 3,881–3,900 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP deviations: Temperature abuse
Recall initiated
April 13, 2022
Reported by FDA
June 15, 2022
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15

by Grato Holdings, Inc.

Reason
Microbial contamination of non-sterile product.
Recall initiated
May 24, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass II

Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15

by Grato Holdings, Inc.

Reason
Microbial contamination of non-sterile product.
Recall initiated
May 24, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass II

Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE AID, 30 Hunter Lane, Camp Hill, PA 17011. NDC 11822-3644-3

by Grato Holdings, Inc.

Reason
Microbial contamination of non-sterile product.
Recall initiated
May 24, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass III

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01

by Teva Pharmaceuticals USA Inc

Reason
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Recall initiated
May 18, 2022
Reported by FDA
June 15, 2022
Distribution
Product was distributed nationwide in the US Market

View recall →

Drug Recall Terminated Historical recordClass II

B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523

by US Specialty Formulations LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 24, 2022
Reported by FDA
June 15, 2022
Distribution
Product was distributed to medical facilities and a physician's office Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229

by US Specialty Formulations LLC

Reason
Lack of Assurance of Sterility
Recall initiated
May 24, 2022
Reported by FDA
June 15, 2022
Distribution
Product was distributed to medical facilities and a physician's office Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.

by Novartis Pharmaceuticals Corporation

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
May 10, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.

by Novartis Pharmaceuticals Corporation

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
May 10, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.

by Novartis Pharmaceuticals Corporation

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
May 10, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.

by Novartis Pharmaceuticals Corporation

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
May 10, 2022
Reported by FDA
June 15, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.

by Teva Pharmaceuticals USA Inc

Reason
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Recall initiated
May 11, 2022
Reported by FDA
June 8, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7

by Family Dollar Stores, Llc.

Reason
cGMP deviations: product stored outside of labeled temperature requirements.
Recall initiated
May 17, 2022
Reported by FDA
June 8, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9

by Family Dollar Stores, Llc.

Reason
cGMP deviations: product stored outside of labeled temperature requirements.
Recall initiated
May 17, 2022
Reported by FDA
June 8, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6

by Family Dollar Stores, Llc.

Reason
cGMP deviations: product stored outside of labeled temperature requirements.
Recall initiated
May 17, 2022
Reported by FDA
June 8, 2022
Distribution
USA Nationwide

View recall →

Data last updated:

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.