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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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Drug Recall Ongoing 2026 recordClass II

Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.

by American Regent, Inc.

Reason: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Recall initiated: July 24, 2026
Reported by FDA: August 26, 2026
Distribution: Nationwide within the U.S

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Drug Recall Ongoing 2026 recordClass I

Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11

by Fresenius Kabi USA, LLC

Reason: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Recall initiated: August 4, 2026
Reported by FDA: August 26, 2026
Distribution: Nationwide within the USA.

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Drug Recall Ongoing 2026 recordClass II

Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.

by MYLAN PHARMACEUTICALS INC

Reason: Failed Dissolution Specifications
Recall initiated: July 24, 2026
Reported by FDA: August 26, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA

by Golden State Medical Supply Inc.

Reason: CGMP deviations: tablets with black specks.
Recall initiated: August 7, 2026
Reported by FDA: August 26, 2026
Distribution: USA Nationwide

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Drug Recall Ongoing 2026 recordClass II

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Recall initiated: August 3, 2026
Reported by FDA: August 26, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass II

Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01

by Regeneron Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Recall initiated: July 28, 2026
Reported by FDA: August 26, 2026
Distribution: USA Nationwide

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Drug Recall Ongoing 2026 recordClass II

PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1

by Shilpa Medicare Limited

Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Recall initiated: July 29, 2026
Reported by FDA: August 26, 2026
Distribution: Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass II

PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1

by Shilpa Medicare Limited

Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Recall initiated: July 29, 2026
Reported by FDA: August 26, 2026
Distribution: Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass I

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

by Baxter Healthcare Corporation

Reason: Presence of Particulate Matter
Recall initiated: July 24, 2026
Reported by FDA: August 19, 2026
Distribution: US Nationwide.

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Drug Recall Ongoing 2026 recordClass I

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.

by Liebel-Flarsheim Company LLC

Reason: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Recall initiated: July 31, 2026
Reported by FDA: August 19, 2026
Distribution: Distributed Nationwide in the US and Mexico.

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Drug Recall Ongoing 2026 recordClass I

Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.

by Victory Medical Center Pharmacy

Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Recall initiated: July 1, 2026
Reported by FDA: August 19, 2026
Distribution: USA Nationwide

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Drug Recall Ongoing 2026 recordClass I

Kian Pee Wan Capsules, 30-count bottles

by Buy-Herbal

Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Recall initiated: March 21, 2026
Reported by FDA: August 19, 2026
Distribution: Product was sold to individual consumers via ebay third party seller.

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Drug Recall Ongoing 2026 recordClass II

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

by Heritage Pharmaceuticals Inc

Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Recall initiated: July 30, 2026
Reported by FDA: August 19, 2026
Distribution: Nationwide within the U.S

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Drug Recall Ongoing 2026 recordClass II

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3

by Prestige Brands Holdings

Reason: Lack of assurance of sterility. The recall is due to potential contamination
Recall initiated: July 29, 2026
Reported by FDA: August 19, 2026
Distribution: Nationwide in the USA.

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Drug Recall Ongoing 2026 recordClass II

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.

by Shoolin Pharma Chem LLP

Reason: CGMP Deviations:Noted during FDA inspection
Recall initiated: August 3, 2026
Reported by FDA: August 19, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

by Shoolin Pharma Chem LLP

Reason: CGMP Deviations:Noted during FDA inspection
Recall initiated: August 3, 2026
Reported by FDA: August 19, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.

by Shoolin Pharma Chem LLP

Reason: CGMP Deviations:Noted during FDA inspection
Recall initiated: August 3, 2026
Reported by FDA: August 19, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

by Shoolin Pharma Chem LLP

Reason: CGMP Deviations:Noted during FDA inspection
Recall initiated: August 3, 2026
Reported by FDA: August 19, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

by Shoolin Pharma Chem LLP

Reason: CGMP Deviations:Noted during FDA inspection
Recall initiated: August 3, 2026
Reported by FDA: August 19, 2026
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.

by Apollo Care, LLC

Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Recall initiated: July 29, 2026
Reported by FDA: August 19, 2026
Distribution: Nationwide within the U.S

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Data last updated: October 29, 2026 ET

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.