By Julia Landwehr and Nick Blackmer
Nearly 40 different kinds of common generic medications are being recalled, according to a report posted by the Food and Drug Administration (FDA).
The medications, all produced by Glenmark Pharmaceuticals, Inc., were initially recalled on March 13. The FDA gave the recall a Class II risk level on April 8.
All of the recalled drugs were manufactured at a Glenmark Pharmaceuticals factory in India, and were flagged by the FDA as deviating from “current good manufacturing practice.”
Which Drugs Were Recalled?
There were 39 different generic medications included in this recall, used to treat dozens of different conditions.
For example, Glenmark Pharmaceuticals recalled certain lots of their fenofibrate capsules—these are a generic form of Tricor, a medication that lowers triglycerides and cholesterol.
Others included medications used to treat atrial fibrillation, seizures, high blood sugar, and high blood pressure, among many others.
Below is a full list of the Glenmark generic medications that were recalled:
- 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-count bottle and 90-count 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
- Colesvelam hydrochloride tablets 625 mg, 180-count bottle
- Pravastatin sodium tablets, 20 mg, 500-count bottle and 90-count 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-count bottle and 90-count bottle
- Naproxen sodium tablets, USP, 550 mg, 100-count bottles
- Acetaminophen and ibuprofen (NSAID) tablets, 250 mg/125 mg, 144-count packets and 216-count packets
- 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
More information on recall numbers, lot numbers, and expiration dates for each recalled medication can be found in the FDA’s enforcement report.
Where Were They Sold?
These recalled generic medications were distributed nationwide.
The majority of them were prescription only, so people likely got them from a pharmacy.
However, certain lots of Glenmark Pharmaceuticals’ acetaminophen and ibuprofen (NSAID) tablets were distributed to Amazon and Walmart. Recalled cetirizine hydrochloride tablets, used to treat seasonal allergy symptoms, were distributed by Amazon.
Why Were These Generic Medications Recalled?
All of the medications included in the recall failed to meet current good manufacturing practice standards, the FDA said.
Following these regulations “includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories,” the FDA said.
According to a February FDA inspection report obtained by ProPublica, the Glenmark Pharmaceuticals site in Madhya Pradesh, India:
- Did not have adequate measures in place to prevent cross-contamination between medications
- Was not taking enough steps to prevent contamination or mix-ups
- Was not properly reviewing medication batches for discrepancies
- Did not document or establish the accuracy of their testing methods
- Had not given the quality control unit enough responsibility to approve procedures
How Dangerous Is This Recall?
All of the recalled medications have been given a Class II recall distinction.
According to the FDA, this means they “may cause temporary or medically reversible adverse health consequences,” however, the ”probability of serious adverse health consequences is remote.”
The FDA’s report did not mention whether there have been any injuries or adverse events in connection to the recalled drugs. It also didn’t provide information about what the specific harm to consumers might be, beyond the fact that the drugs weren’t produced in line with current good manufacturing practices.
However, this same Glenmark Pharmaceuticals plant in India was the subject of a ProPublica investigation last year—the manufacturer had to issue multiple recalls in 2024 due to issues with their extended-release potassium chloride medication.
The company received reports of three deaths and three hospitalizations among patients who had taken the recalled potassium chloride drugs, though it wasn’t clear if the drug itself was to blame, according to ProPublica. There’s also a federal lawsuit against the company, which alleges that these faulty drugs caused the death of a woman in Maine.
Check Your Medicine Cabinet, and Dispose of Any Recalled Drugs
Though the FDA didn’t offer any guidance to consumers in their recall report, anybody who has any of these recalled Glenmark Pharmaceuticals medications should stop taking them.
In particular, people taking prescription drugs should get in touch with their physician if necessary to discuss options to access a safe version.
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