- FURTHER READING: Drug Recalled Due to Fears It May Cause Lethal Brain Infections
Almost 40 crucial medicines have been withdrawn from use by the Food and Drug Administration. fears of faulty manufacturing .
All the drugs were generic versions made by Glenmark Pharmaceuticals Inc at their facility. India and were first called back on March 13.
The FDA gave the recall a Level II risk classification on April 8, characterized as an item that might lead to temporary or medically reversible adverse health effects.
The medications were utilized for treating epilepsy. diabetes , multiple sclerosis, heart conditions, and hypertension. Others also address issues with kidneys and bladders, atrial fibrillation (uneven heartbeat), strokes, as well as convulsions.
The federal body pointed out that the manufacturing process did not comply with their Current Good Manufacturing Practice (CGMP) regulations – guidelines designed to guarantee that drugs are produced safely and uniformly.
As of now, experts do not expect the recalled tablets to cause any serious illnesses or death in patients.
According to Glenmark's website, all of its tablets and capsules have it signature 'G' imprinted - making them easily recognizable to patients.
Patients using any of the 39 recalled medications are advised to contact their pharmacist, physician or medical provider to discuss next steps.
Some of the popular drugs that have been listed include Fenofibrate capsules 67 mg (used to lower blood fat levels and help blood pressure), Solifenacin Succinate 10 mg (used to treat bladder problems including an overactive bladder) and Gabapentin tablets 600 mg (used to treat partial seizures, nerve pain from shingles and restless leg syndrome).
The majority of the drugs were prescription only, meaning that most people received them from a pharmacy.
However, certain lots of Glenmark Pharmaceuticals’ acetaminophen and ibuprofen (NSAID) tablets were distributed to Amazon and Walmart.
A number of the recalled cetirizine hydrochloride tablets, which are meant for treating seasonal allergies, were also sold through Amazon.
Neither of the retail behemoths has addressed whether they plan to issue a recall for the tablets.
In June 2024, Glenmark Pharmaceuticals issued 135 lots of blood pressure medications that were also recalled due to concerns that the medicine capsules doesn't fully break down when consumed by patients.
They initiated a voluntary recall Of the 114 lots of 750 mg Potassium Chloride tablets packaged in bottles holding 100 and 500 pills each, detailed listings for every particular lot number along with their respective expiry dates can be found. a document circulated by the FDA .
Likewise, American Health Packaging voluntarily recalled 21 batches of the same medicine on behalf of BluePoint Laboratories.
According to a company announcement , the failed dissolution of the potassium chloride extended release capsules could cause high potassium levels in the blood, also known as hyperkalemia.
| Fenofibrate capsules 67 mg USP | 100-count bottle |
| Propafenone hydrochloride extended-release capsules 225 mg | 60-count bottle |
| Propafenone hydrochloride extended-release capsules 325 mg | 60-count bottle |
| Solifenacin succinate tablets 10 mg | 30-unit bottle and 90-unit bottle |
| Voriconazole tablets 200 mg | 30-count bottle |
| Voriconazole tablets 50 mg | 30-count bottle |
| Gabapentin tablets 600 mg | 500-count bottles |
| Lacosamide tablets 200 mg | 60-count bottle |
| Frovatriptan succinate tablets 2.5 mg | 9-count bottle |
| Rufinamide tablets 200 mg | 120-count bottle |
| Nitroglycerin sublingual tablets 0.4 mg | 100-count carton |
| Pravastatin sodium tablets 80 mg | 90-count bottle |
| Fluphenazine hydrochloride tablets 10 mg | 100-count Bottle |
| Fluphenazine hydrochloride tablets 2.5 mg | 100-count bottle |
| Metformin hydrochloride extended-release tablets 1000 mg | 90-count bottle |
| Indomethacin extended-release capsules 75 mg | 60-count bottles |
| Lacosamide tablets 100 mg | 60-count bottle |
| Nitroglycerin sublingual tablets 0.3 mg | 100-count bottles |
| Saxagliptin tablets 5 mg | 30-count bottle and 90-count bottle |
| Solifenacin succinate tablets 5 mg | 30-count bottle and 90-count bottle |
| Teriflunomide tablets 14 mg | 30-count bottle |
| Ranolazine extended-release tablets 1000 mg | 60-count bottle |
| Carvedilol tablets USP 12.5 mg | 500-count bottle |
| Lacosamide tablets 50 mg | 60-count bottles |
| Prochlorperazine maleate tablets 10 mg | 100-count bottles |
| Rosuvastatin tablets 40 mg | 30-count bottle |
| Colestvelam hydrochloride tablets 625 mg | 180-count bottle |
| Pravastatin sodium tablets 20 mg | A 500-unit bottle and a 90-unit bottle |
| Diltiazem hydrochloride extended-release capsules 12HR 120 mg | 100-count bottle |
| Lacosamide tablets 150 mg | 60-count bottle |
| Clindamycin hydrochloride capsules USP 300 mg | 100-count bottles |
| Saxagliptin tablets USP 2.5 mg | 30-unit bottle and 90-unit bottle |
| Naproxen sodium tablets USP 550 mg | 100-count bottles |
| Paracetamol and ibuprofen (non-steroidal anti-inflammatory drug) tablets 250 mg/125 mg | 144-unit packs and 216-unit packs |
| Cetirizine hydrochloride tablets USP 10 mg | 365-count packs |
| Pravastatin sodium tablets USP 20 mg | 90-count bottle |
| Pravastatin sodium tablets USP 80 mg | 90-count bottle and 500-count bottle |
| Propafenone hydrochloride extended-release capsules USP 225 mg | 60-count bottles |
| Propafenone hydrochloride extended-release capsules USP 325 mg | 60-count bottles |