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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 601–620 of 18,047 drug recalls

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.

by F.H. INVESTMENTS, Inc. (dba Asteria Health)

Reason
Presence of Foreign substance - potential presence of metal particulate matter
Recall initiated
January 26, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass III

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.

by Unichem Pharmaceuticals USA Inc.

Reason
Tablets/Capsules Imprinted with Wrong ID
Recall initiated
January 21, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

by Pro Numb Tattoo Numbing Spray LLC

Reason
cGMP deviations
Recall initiated
February 2, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11

by Pro Numb Tattoo Numbing Spray LLC

Reason
cGMP deviations
Recall initiated
February 2, 2026
Reported by FDA
February 18, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Recall initiated
January 27, 2026
Reported by FDA
February 11, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass I

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

by HANDELNINE GLOBAL LLC

Reason
CGMP Deviations: product found to contain lead.
Recall initiated
December 22, 2025
Reported by FDA
February 11, 2026
Distribution
Product was distributed to one customer in NY.

View recall →

Drug Recall Ongoing 2026 recordClass II

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.

by Granules Pharmaceuticals Inc.

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
January 26, 2026
Reported by FDA
February 11, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass I

Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660

by Green Lumber Holdings, LLC

Reason
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Recall initiated
August 28, 2025
Reported by FDA
February 11, 2026
Distribution
Nationwide

View recall →

Drug Recall Ongoing 2026 recordClass II

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01

by Unichem Pharmaceuticals USA Inc.

Reason
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Recall initiated
January 21, 2026
Reported by FDA
February 11, 2026
Distribution
US Nationwide and PR.

View recall →

Drug Recall Ongoing 2026 recordClass III

Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72

by NOVADOZ PHARMACEUTICALS LLC

Reason
Failed Impurities/Degradation Specifications
Recall initiated
December 15, 2025
Reported by FDA
February 4, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2

by Greenstone Llc

Reason
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Recall initiated
January 15, 2026
Reported by FDA
February 4, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01

by Sato Pharmaceutical Co., Ltd

Reason
Failed Disintegration Specifications: above the time expected.
Recall initiated
December 19, 2025
Reported by FDA
February 4, 2026
Distribution
CA and HI

View recall →

Drug Recall Ongoing 2026 recordClass III

parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02

by Haleon US Holdings LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Recall initiated
December 26, 2025
Reported by FDA
February 4, 2026
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.

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