Class II Drug Recalls

The 20 most recently initiated drug recalls from FDA enforcement reports, limited to Class II - Potentially Harmful recalls. Class I means a reasonable probability of serious harm or death, Class II a temporary or reversible health risk, and Class III a product unlikely to cause harm. Dates are recall initiation dates.

All Class I Class II Class III

Class II2026-09-15

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

Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Class II2026-09-15

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bott

Lack of Assurance of Sterility

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Class II2026-09-04

Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA,

Lack of Assurance of Sterility

Class II2026-09-03

fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 730

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/

Class II2026-09-03

Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01

Failed Dissolution Specifications

Inventia Healthcare Limited

Class II2026-08-31

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro P

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stab

SUN PHARMA /TARO

Class II2026-08-28

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 P

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

Amneal Pharmaceuticals of New York, LLC

Class II2026-08-26

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC,

Failed Dissolution Specifications

Mylan Pharmaceuticals Inc

Class II2026-08-24

Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for

Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

Hikma Pharmaceuticals USA INC.

Class II2026-08-24

traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For

Presence of Foreign Tablets/Capsules

Teva Pharmaceuticals USA, Inc

Class II2026-08-21

Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Frankl

CGMP Deviations: Potential contamination of raw material

Class II2026-08-21

Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway J

CGMP Deviations: Potential contamination of raw material

Class II2026-08-21

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissoluti

Golden State Medical Supply Inc.

Class II2026-08-20

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactur

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC

Class II2026-08-20

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

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC

Class II2026-08-20

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC

Class II2026-08-20

Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Phar

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC

Class II2026-08-20

Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Labora

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC

Class II2026-08-20

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, Deerfield,

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC

Class II2026-08-20

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

Lack of Assurance of Sterility

Sterling Pharmaceutical Services LLC