Drug Recalls

The 20 most recently initiated drug recalls from FDA enforcement reports. 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

Not Yet Classified2026-09-14

Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U

Failed Stability Specifications

SUN PHARMACEUTICAL INDUSTRIES INC

Not Yet Classified2026-09-11

0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.

Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to

Otsuka ICU Medical LLC

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 III2026-08-31

Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA

Failed dissolution specifications.

Supernus Pharmaceuticals, Inc.

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 III2026-08-27

Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Ph

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

Macleods Pharmaceuticals Limited

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 III2026-08-25

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India,

Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18

Ajanta Pharma USA 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 III2026-08-24

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 We

Subpotent Drug

ImprimisRx NJ LLC

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 I2026-08-21

Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed

Superpotent Drug

VITRUVIAS THERAPEUTICS INC

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.