Prescription medicine recalls

Par Health USA, LLC — Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials

Crystallization

Amneal Pharmaceuticals, LLC — Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only

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

Pfizer — Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only

Lack of Assurance of Sterility

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter

FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B.

American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc.

Inventia Healthcare Limited — Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only

Failed Dissolution Specifications

OurPharma LLC — 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 73013-1013-01.

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and…

SV Labs Toronto Corporation — Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL)

Microbial contamination of topical product.

SV Labs Toronto Corporation — 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)

Microbial contamination of topical product.

Supernus Pharmaceuticals, Inc. — Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only

Failed dissolution specifications.

TerSera Therapeutics LLC — Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only

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

Amneal Pharmaceuticals of New York, LLC — Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only

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

Macleods Pharmaceuticals Limited — Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only

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

Mylan Pharmaceuticals Inc — Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only

Failed Dissolution Specifications

Ajanta Pharma USA Inc — Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only

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

Baxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection

FOR IMMEDIATE RELEASE – AUG.

Baxter Issues Voluntary Nationwide Recall for One Lot of 70% Dextrose Injection

FOR IMMEDIATE RELEASE – AUG.

Teva Pharmaceuticals USA, Inc — traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets

Presence of Foreign Tablets/Capsules

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

ImprimisRx NJ LLC — 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 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10

Subpotent Drug

Hikma Pharmaceuticals USA INC. — 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

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