FDA Alerts: Severe Itching Risk After Stopping Long-Term Use of Cetirizine or Levocetirizine
What’s the Issue? On May 16, 2025, the FDA issued a Drug Safety Communication warning that discontinuation of cetirizine (Zyrtec) or levocetirizine (Xyzal)—after long-term, daily use—can cause rare but severe and widespread itching (pruritus), sometimes requiring medical attention. This risk applies to both prescription and over-the-counter (OTC) forms. U.S. Food and Drug AdministrationPeople.com How Often […]
Breaking: Amneal Issues Nationwide Recall of Sulfamethoxazole/Trimethoprim Tablets Due to Microbial Contamination
What’s Being Recalled? On June 2, 2025, Amneal Pharmaceutical LLC initiated a nationwide recall of three specific lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, due to microbial contamination. Tablets from the affected lots may display black spots, identified as Aspergillus, a potentially harmful fungus. This recall only applies to two pack sizes—100-count and 500-count […]
FDA Mandates New Warnings on Extended-Release ADHD Stimulants
What’s Changing? On June 30, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication requiring all manufacturers of extended-release (ER) stimulants—including both amphetamine and methylphenidate formulations—used for attention-deficit/hyperactivity disorder (ADHD) to revise their prescribing information (PI). The update mandates inclusion of a “Limitation of Use” section highlighting that children under 6 years […]
FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use: Drug Safety Communication
Breaking Down the FDA’s Latest Mandate on Opioid Labeling What’s Going On? On July 31, 2025, the FDA released a class-wide Drug Safety Communication mandating that all opioid pain medicine manufacturers update prescribing information to better reflect the risks of long-term use U.S. Food and Drug AdministrationHHS.gov. This follows observational data from two post-marketing studies—PMR […]
Mispackaged Antibiotics: An Investigative Spotlight on Sandoz’s Nationwide Recall
A Critical Mix-Up: What Exactly Happened On June 27, 2025, Sandoz Inc. initiated a voluntary nationwide recall of a single lot of Cefazolin for Injection, USP (1 g vials)—lot number PG4360, with expiration November 2027—after a customer complaint revealed that four vials of Penicillin G Potassium were mistakenly packaged inside a carton intended for Cefazolin […]
DermaRite Recall: How Burkholderia cepacia Contaminated DermaKleen, KleenFoam, DermaSarra & PeriGiene—What You Need to Know
1. Introduction / Hook Start strong with urgency and clarity: On August 8, 2025, DermaRite Industries, LLC issued a voluntary nationwide recall of several OTC hygiene products—including DermaKleen, KleenFoam, DermaSarra, and PeriGiene—due to contamination by the antibiotic-resistant bacterium Burkholderia cepacia, which can cause severe and potentially life-threatening infections. U.S. Food and Drug AdministrationPeople.com 2. What’s […]
Case Study: Voluntary Nationwide Recall of Sucralfate Tablets USP 1 g by Nostrum Laboratories
1. Background Sucralfate Tablets USP 1 g are an oral gastrointestinal medication primarily used in the prevention and treatment of duodenal ulcers, gastric ulcers, and conditions associated with excess stomach acid. The product works by forming a protective barrier over ulcerated tissue, shielding it from gastric acid. Manufacturer: Nostrum Laboratories, Inc., a U.S.-based pharmaceutical company […]
Amneal Pharmaceutical LLC Nationwide Recalling Issued as Mysterious Black Spots Trigger Safety Concern in Antibiotic
Bridgewater, NJ — June 2, 2025 — A routine quality check turned into a nationwide safety alert when Amneal Pharmaceutical LLC quietly began recalling certain batches of a commonly used antibiotic—and the culprit? Tiny black specks. Tiny Dots, Big Alarm What seemed like a cosmetic defect—black spots on the surface of Sulfamethoxazole/Trimethoprim (400 mg/80 mg) tablets—set off alarm bells. […]
Major Recall Alert: Azurity Pharmaceuticals Pulls One Lot of Zenzedi® 30 mg
What Happened On January 24, 2024, Azurity Pharmaceuticals, Inc. voluntarily recalled a single lot (Lot F230169A, NDC 24338‑856‑03, expiry June 2025) of Zenzedi® (dextroamphetamine sulfate) 30 mg tablets, distributed nationwide through U.S. pharmacies U.S. Food and Drug Administration+12U.S. Food and Drug Administration+12Louisiana Department of Health+12. Why the Recall Was Issued A Nebraska pharmacist discovered that a bottle labeled as […]