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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 4,941–4,960 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

by Fresenius Kabi USA LLC

Reason
Defective container: Cracked vials leading to lack of sterility assurance
Recall initiated
September 17, 2021
Reported by FDA
October 6, 2021
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass III

CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895

by New Vision Pharmaceuticals LLC

Reason
Subpotent Drug
Recall initiated
September 2, 2021
Reported by FDA
October 6, 2021
Distribution
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA

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Drug Recall Ongoing Historical recordClass II

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

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Drug Recall Ongoing Historical recordClass II

Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

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Drug Recall Ongoing Historical recordClass II

Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11033 0

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

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Drug Recall Ongoing Historical recordClass II

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

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Drug Recall Ongoing Historical recordClass II

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed by JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Ongoing Historical recordClass II

Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skillman, NJ 08858,

by Johnson & Johnson Consumer, Inc.

Reason
cGMP Deviations
Recall initiated
July 14, 2021
Reported by FDA
October 6, 2021
Distribution
Nationwide in US

View recall →

Drug Recall Terminated Historical recordClass I

Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

by DuPont Nutrition USA, Inc

Reason
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
Product was distributed to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

by Direct Rx

Reason
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Recall initiated
September 14, 2021
Reported by FDA
September 29, 2021
Distribution
FL only

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Drug Recall Terminated Historical recordClass II

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03

by AVRIO HEALTH L.P

Reason
Subpotent Drug
Recall initiated
August 26, 2021
Reported by FDA
September 29, 2021
Distribution
Product was distributed nationwide.

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Drug Recall Terminated Historical recordClass II

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35

by Glenmark Pharmaceuticals Inc., USA

Reason
Lack of Assurance of Sterility
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations
Recall initiated
August 27, 2021
Reported by FDA
September 29, 2021
Distribution
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.