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Recalls

Drug Recalls Today

Drug recalls and enforcement reports from the FDA, last 120 days

Data updated Oct 28, 2026 · 6:02 AM EDT
Recalls Listed
60
Last 120 days
Last 30 Days
60
New reports
Class I
0
Most serious risk
Snapshot

The FDA has published 60 drug recall reports in the last 30 days. The most recent, reported October 21, involves Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston… from Houston Rx LLC — reason: Lack of process control Class I recalls are the most serious, meaning the product could cause serious health problems or death.

Latest Drug Recalls

Class IIOct 21, 2026
Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Reason: Lack of process control

Houston Rx LLC · Distribution: Nationwide in the USA. · Ongoing

Class IIOct 21, 2026
Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500…

Reason: Presence of Foreign Tablets/Capsules

Teva Pharmaceuticals USA, Inc · Distribution: US Nationwide. · Ongoing

Class IIOct 21, 2026
Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose:…

Reason: Presence of Foreign Tablets/Capsules

American Health Packaging · Distribution: US Nationwide · Ongoing

Class IIOct 21, 2026
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA)…

Reason: Failed Impurities/Degradation Specifications.

Zydus Pharmaceuticals (USA) Inc · Distribution: Nationwide within the United States · Ongoing

Class IIOct 21, 2026
Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Reason: Lack of assurance of sterility.

Houston Rx LLC · Distribution: Nationwide in the USA. · Ongoing

Class IIOct 14, 2026
Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,…

Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,…

Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,…

Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,…

Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for:…

Reason: Failed Impurities/Degradation Specifications

Cipla USA, Inc. · Distribution: USA Nationwide. · Ongoing

Class IIOct 14, 2026
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA…

Reason: Presence of particulate matter.

J&J INNOVATIVE MEDICINE · Distribution: OH · Ongoing

Class IIOct 14, 2026
Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best Choice, PROUDLY DISTRIBUTED BY:…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.

Reason: Lack of Assurance of Sterility

Apothecary Pharma LLC · Distribution: Nationwide within the United States · Ongoing

Class IIOct 14, 2026
Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05

Reason: Failed Content Uniformity Specifications

Preferred Pharmaceuticals, Inc. · Distribution: USA Nationwide · Ongoing

Class IIOct 14, 2026
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIIOct 14, 2026
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product…

Reason: Failed Impurities/Degradation Specifications

SUN PHARMACEUTICAL INDUSTRIES INC · Distribution: US Nationwide. · Ongoing

Class IIOct 14, 2026
TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIIOct 14, 2026
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532,…

Reason: Failed Impurities/Degradation Specifications

SUN PHARMACEUTICAL INDUSTRIES INC · Distribution: US Nationwide. · Ongoing

Class IIOct 14, 2026
Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176,…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25

Reason: Failed stability specifications

BioSpectra, Inc. · Distribution: CA · Ongoing

Not Yet ClassifiedOct 14, 2026
Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suite 111, Houston, TX…

Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Centric Compounding LLC · Distribution: USA Nationwide. · Ongoing

Class IIOct 14, 2026
TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.,…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIIOct 14, 2026
Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY…

Reason: Failed Impurities/Degradation Specifications

SUN PHARMACEUTICAL INDUSTRIES INC · Distribution: US Nationwide. · Ongoing

Class IIOct 14, 2026
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek…

Reason: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

Carolina Infusion, LLC · Distribution: Nationwide within the U.S · Ongoing

Class IIOct 14, 2026
Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER,…

Reason: Lack of Assurance of Sterility

K.C. Pharmaceuticals, Inc. · Distribution: US Nationwide · Ongoing

Class IIOct 14, 2026
Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.

Reason: Lack of Assurance of Sterility

Apothecary Pharma LLC · Distribution: Nationwide within the United States · Ongoing

Class IIOct 7, 2026
Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by:…

Reason: Microbial contamination of topical product.

SV Labs Toronto Corporation · Distribution: IL only · Ongoing

Class IIOct 7, 2026
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.

Reason: Defective Container; packets were found to be either empty or partially full.

Amneal Pharmaceuticals, LLC · Distribution: Nationwide in the USA. · Ongoing

Class IIOct 7, 2026
FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19

Reason: Lack of Assurance of Sterility

Aurolab Trust · Distribution: VA · Ongoing

Class IIOct 7, 2026
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited,…

Reason: Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

TerSera Therapeutics LLC · Distribution: USA Nationwide · Ongoing

Not Yet ClassifiedOct 7, 2026
amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC…

Reason: Discoloration: consumer complaints received for discolored tablets

Aurobindo Pharma USA Inc · Distribution: US Nationwide. · Ongoing

Class IIOct 7, 2026
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3

Reason: Failed dissolution specifications.

Apotex Corp. · Distribution: US Nationwide. · Ongoing

Class IIOct 7, 2026
Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63

Reason: Microbial contamination of topical product.

SV Labs Toronto Corporation · Distribution: IL only · Ongoing

Class IIOct 7, 2026
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

Reason: Crystallization

Par Health USA, LLC · Distribution: U.S. Nationwide · Ongoing

Class IIOct 7, 2026
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

Reason: Failed Dissolution Specifications: below specification

Ajanta Pharma USA Inc · Distribution: Nationwide in the US. · Ongoing

Class IISep 30, 2026
TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company,…

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack,…

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by…

Reason: Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Distribution: Nationwide in the USA. · Ongoing

Class IISep 30, 2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC…

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road,…

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.,…

Reason: Defective Delivery System: Possibility of no medication in the prefilled pen.

Amneal Pharmaceuticals of New York, LLC · Distribution: USA Nationwide · Ongoing

Class IIISep 30, 2026
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh,…

Reason: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Macleods Pharmaceuticals Limited · Distribution: Nationwide in the USA · Ongoing

Class IISep 30, 2026
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152,…

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,…

Reason: Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC · Distribution: USA Nationwide · Ongoing

Class IISep 30, 2026
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products…

Reason: Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Distribution: Nationwide in the USA. · Ongoing

Latest Recalls News

All news →

Frequently Asked Questions

What do FDA recall classes mean?

Class I: a reasonable probability the product will cause serious health problems or death. Class II: may cause temporary or medically reversible problems. Class III: unlikely to cause adverse health consequences.

What should I do if I have a recalled product?

Stop using it, check the lot or batch number against the recall, and follow the company's instructions for a refund or disposal. Contact a doctor if you think you have been harmed.

Data source & method: U.S. Food & Drug Administration (openFDA). Data updated Oct 28, 2026 · 6:02 AM EDT. This page refreshes automatically; figures are shown exactly as published by the source. How we source data.