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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 581–600 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02

by CA BOTANA International, Inc.

Reason
CGMP Deviations
Recall initiated
October 10, 2025
Reported by FDA
December 3, 2025
Distribution
CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05

by CA BOTANA International, Inc.

Reason
CGMP Deviations
Recall initiated
October 10, 2025
Reported by FDA
December 3, 2025
Distribution
CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05

by CA BOTANA International, Inc.

Reason
CGMP Deviations
Recall initiated
October 10, 2025
Reported by FDA
December 3, 2025
Distribution
CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17

by CA BOTANA International, Inc.

Reason
CGMP Deviations
Recall initiated
October 10, 2025
Reported by FDA
December 3, 2025
Distribution
CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass II

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02

by CA BOTANA International, Inc.

Reason
CGMP Deviations
Recall initiated
October 10, 2025
Reported by FDA
December 3, 2025
Distribution
CA, CO, FL, PR, WA

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Drug Recall Ongoing Historical recordClass I

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

by Fresenius Kabi USA, LLC

Reason
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall initiated
November 6, 2025
Reported by FDA
December 3, 2025
Distribution
Nationwide within the United States as well as AK, HI, and PR.

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Drug Recall Ongoing Historical recordClass II

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01

by Medical Products Laboratories, Inc.

Reason
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Recall initiated
November 12, 2025
Reported by FDA
December 3, 2025
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

by Otsuka ICU Medical LLC

Reason
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Recall initiated
October 29, 2025
Reported by FDA
November 26, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14

by Otsuka ICU Medical LLC

Reason
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Recall initiated
October 29, 2025
Reported by FDA
November 26, 2025
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

by Park Avenue Compounding

Reason
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Recall initiated
September 23, 2025
Reported by FDA
November 26, 2025
Distribution
Distributed in Missouri

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Drug Recall Ongoing Historical recordClass II

UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

by DermaRite Industries, LLC

Reason
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Recall initiated
August 27, 2025
Reported by FDA
November 26, 2025
Distribution
Nationwide in the USA

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.