PlainRecalls
2023 data Federal recall API Linked to agency record

FDA Drug Safety

All recall actions attributed to FDA Drug Safety in our federal database. Each record links back to the agency's official notice so you can verify status, remedy, and amendments before acting.

U.S. Food and Drug Administration — Drug recalls and safety communications

17,683 recalls · Page 5 of 354

Official website →

FDA Drug Safety Recall Insight

PlainRecalls tracks 17,683 recall actions attributed to the FDA Drug Safety in our federal recall index. Across the full PlainRecalls database of 83,949 records spanning 1995 through 2026, FDA Drug Safety accounts for roughly 21.1% of all indexed recalls. The agency's stated scope — U.S. Food and Drug Administration — Drug recalls and safety communications — determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 354 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.

Looking at the 50 records on this page alone, the severity distribution skews toward 2 critical (Class I-equivalent) actions, 46 moderate recalls, and 2 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 50 disclose a unit count — the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Feb 11, 2026 to Mar 4, 2026, covering 14 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.

Agency-level browsing is useful when a defect pattern crosses categories — for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Drug Safety's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions — medical, automotive, or childcare — always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).

Moderate Mar 4, 2026

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura…

Wizcure Pharmaa Private Limited

Moderate Mar 4, 2026

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manu…

Wizcure Pharmaa Private Limited

Low Mar 4, 2026

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufacture…

Slate Run Pharmaceuticals

Moderate Mar 4, 2026

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 5026…

AvKARE

Moderate Mar 4, 2026

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO I…

Wizcure Pharmaa Private Limited

Moderate Mar 4, 2026

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single d…

LEO PHARMA INC

Moderate Mar 4, 2026

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-88…

Wizcure Pharmaa Private Limited

Moderate Mar 4, 2026

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

Agebox

Moderate Mar 4, 2026

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-…

Wizcure Pharmaa Private Limited

Moderate Mar 4, 2026

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0

Agebox

Moderate Mar 4, 2026

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufacture…

Wizcure Pharmaa Private Limited

Critical Feb 18, 2026

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporat…

McKesson

Moderate Feb 18, 2026

Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.

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

Moderate Feb 18, 2026

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, Melbourn…

Pro Numb Tattoo Numbing Spray LLC

Moderate Feb 18, 2026

thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-…

Fresenius Kabi Compounding, LLC

Moderate Feb 18, 2026

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC …

Fresenius Kabi Compounding, LLC

Moderate Feb 18, 2026

Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package…

Amerisource Health Services LLC

Moderate Feb 18, 2026

Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

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

Moderate Feb 18, 2026

Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.

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

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, ND…

Fresenius Kabi Compounding, LLC

Moderate Feb 18, 2026

Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.

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

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.

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

Moderate Feb 18, 2026

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71…

Fresenius Kabi Compounding, LLC

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.

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

Low Feb 18, 2026

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2…

Unichem Pharmaceuticals USA Inc.

Moderate Feb 18, 2026

Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.

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

Moderate Feb 18, 2026

Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01.

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

Moderate Feb 18, 2026

Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

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

Moderate Feb 18, 2026

Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.

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

Moderate Feb 18, 2026

ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.

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

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 2…

Fresenius Kabi Compounding, LLC

Moderate Feb 18, 2026

Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

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

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.

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

Moderate Feb 18, 2026

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

Meitheal Pharmaceuticals, Inc

Moderate Feb 18, 2026

Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.

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

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.

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

Moderate Feb 18, 2026

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 …

Pro Numb Tattoo Numbing Spray LLC

Moderate Feb 18, 2026

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

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

Moderate Feb 18, 2026

Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32

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

Moderate Feb 18, 2026

Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.

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

Moderate Feb 18, 2026

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

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

Moderate Feb 11, 2026

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Piler…

Unichem Pharmaceuticals USA Inc.

Critical Feb 11, 2026

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, New…

Green Lumber Holdings, LLC

Moderate Feb 11, 2026

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for:…

Granules Pharmaceuticals Inc.

Nearby Agencies

Explore recalls from other federal agencies that share oversight of product safety.

Compare FDA Drug Safety with FDA Medical Devices →

Learn More About Recalls

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Consult a qualified professional before making decisions based on this data.