Class III Drug Recalls

The 20 most recently initiated drug recalls from FDA enforcement reports, limited to Class III - Minor Violations 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.

AllClass IClass IIClass III
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 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 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 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 III2026-08-19
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton ND

Labeling: Label Mix-up

American Health Packaging
Class III2026-08-19
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary

Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

Chiesi USA, Inc.
Class III2026-08-07
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc.

Presence of Foreign Tablets/Capsules

Bionpharma Inc.
Class III2026-07-16
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mum

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II,

Ascend Laboratories, LLC
Class III2026-07-16
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mu

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II,

Ascend Laboratories, LLC
Class III2026-07-16
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injectio

Incorrect Product Formulation

Central Admixture Pharmacy Services Inc
Class III2026-07-16
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., M

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II,

Ascend Laboratories, LLC
Class III2026-07-15
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, T

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Asclemed USA Inc.
Class III2026-07-06
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, M

Failed Dissolution Specifications

Supernus Pharmaceuticals, Inc.
Class III2026-06-30
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Phar

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with re

Ascend Laboratories, LLC
Class III2026-06-30
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Phar

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with re

Ascend Laboratories, LLC
Class III2026-06-03
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 3

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue

Amneal Pharmaceuticals, LLC
Class III2026-06-02
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. ND

Presence of foreign substance

ANI Pharmaceuticals, Inc.
Class III2026-06-01
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901

Failed Impurities/Degradation Specifications

SUN PHARMACEUTICAL INDUSTRIES INC
Class III2026-06-01
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesvill

Labeling: Incorrect or Missing Lot and/or Exp Date

Sandoz Inc
Class III2026-05-18
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. ND

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Eugia US LLC