Nationwide Recall Hits Dozens of Common Generic Drugs

Glenmark Pharmaceuticals Inc. has voluntarily recalled nearly 40 types of generic medications after U.S. regulators found problems with how the drugs were manufactured at a facility in India, the Food and Drug Administration (FDA) has announced. 

The medications were cited for CGMP deviations, which means the company failed to comply with the FDA's regulations for manufacturing practices, affecting the quality and safety of medications, potentially leading to adverse health effects.

Though everyone is exposed to some risk from manufacturing deviations, the FDA sets strict guidelines to ensure medications are produced safely and effectively to minimize health risks.

Advice to consumers

Patients using the recalled medications are advised to continue their treatment and contact their pharmacist, physician, or medical provider to discuss alternative options.

Consumers with questions regarding this recall should contact Glenmark Pharmaceuticals Inc. at 877-538-8445 between 9 a.m. and 5 p.m. EST Monday through Friday.

Negative reactions or quality issues resulting from use of recalled items may also be reported to the FDA’s MedWatch adverse event reporting program.

Recalled medications

The recalled medications are used to treat a variety of common conditions, including heart disease, high cholesterol, diabetes, epilepsy, psychiatric disorders, and various types of pain and infections. They are:

Acetaminophen and Ibuprofen (NSAID) tablets 250 mg/125 mg – 144-count and 216-count packets, sold by Walmart and Amazon

• Lot Numbers: 17241302, 17241140, 17241141
• Expiration Date: July 2026
• Recall Number: D-0347-2025

Carvedilol tablets USP 12.5 mg – 500-count bottle

• Lot Numbers: 17240238, 17240243, 17240245, 17240248
• Expiration Date: January 2026
• Recall Number: D-0336-2025

Cetirizine Hydrochloride tablets, USP, 10mg, 365-count packs, sold by Walmart and Amazon

• Lot numbers: 17231980, 17232044, 17241436, 17241437, 17241455, 17241456, 17241457, 17241892, 17241893
• Expiration dates: Aug-25, Jul-26, Aug-26, Oct-26
• Recall Number: D-0348-2025

Clindamycin Hydrochloride capsules USP 300 mg – 100-count bottles

• Lot Numbers: 17241278, 17241297, 17241304, 17241315, 17241327
• Expiration Date: July 2026
• Recall Number: D-0344-2025

Colesevelam Hydrochloride tablets 625 mg – 180-count bottle

• Lot Numbers: 17240669, 17240876, 17240883, 17240909, 17240914, 17240927
• Expiration Dates: March 2026 to May 2026
• Recall Number: D-0340-2025

Diltiazem Hydrochloride extended-release capsules 12HR 120 mg – 100-count

• Lot Numbers: 17241067, 17241628
• Expiration Dates: May 2026, August 2026
• Recall Number: D-0342-2025

Fenofibrate capsules 67 mg, USP – 100-count bottle

• Lot Numbers: 17230834, 17230835
• Expiration Date: March 2025
• Recall Number: D-0314-2025

Fluphenazine Hydrochloride tablets 2.5 mg – 100-count bottle

• Lot Number: 17232214
• Expiration Date: September 2025
• Recall Number: D-0327-2025

Fluphenazine Hydrochloride Tablets 10 mg – 100-count bottle

• Lot Number: 17232206
• Expiration Date: September 2025
• Recall Number: D-0326-2025

Frovatriptan Succinate tablets 2.5 mg – 9-count bottle

• Lot Numbers: 17231352, 17231649
• Expiration Dates: June 2025 to July 2025
• Recall Number: D-0322-2025

Gabapentin tablets 600 mg – 500-count bottles

• Lot Numbers: 17231015, 17231128, 17231138, 17231139, 17231143, 17231144, 17231848, 17231898, 17231977, 17231978, 17232015, 17232016
• Expiration Dates: April 2025 to August 2025
• Recall Number: D-0320-2025

Frovatriptan Succinate tablets 2.5 mg – 9-count bottle

• Lot Numbers: 17231352, 17231649
• Expiration Dates: June 2025 to July 2025
• Recall Number: D-0322-2025

Gabapentin tablets 600 mg – 500-count bottles

• Lot Numbers: 17231015, 17231128, 17231138, 17231139, 17231143, 17231144, 17231848, 17231898, 17231977, 17231978, 17232015, 17232016
• Expiration Dates: April 2025 to August 2025
• Recall Number: D-0320-2025

Indomethacin extended-release capsules 75 mg – 60-count bottle

• Lot Numbers: 17232323, 17232335
• Expiration Date: October 2025
• Recall Number: D-0329-2025

Lacosamide Tablets 50mg, 60-count bottle

• Lot Numbers: 17240221, 17240222
• Expiration Date: January 2026
• Recall Number: D-0337-2025

Lacosamide tablets 100 mg – 60-count bottle

• Lot Numbers: 17232533, 17232534, 17240606, 17240619, 17240911, 17240912, 17241121, 17241124
• Expiration Dates: November 2025 to June 2026
• Recall Number: D-0330-2025

Lacosamide tablets 150 mg – 60-count bottle

• Lot Numbers: 17241125, 17242202, 17242204
• Expiration Dates: June 2026, November 2026, December 2026
• Recall Number: D-0343-2025

Lacosamide tablets 200 mg – 60-count bottle

• Lot Numbers: 17230982, 17230986, 17231001, 17240197, 17240198, 17240215, 17240846, 17240847
• Expiration Dates: April 2025 to April 2026
• Recall Number: D-0321-2025

Metformin Hydrochloride extended-release tablets 1000 mg – 90-count bottle

• Lot Numbers: 17232088, 17232093
• Expiration Date: September 2025
• Recall Number: D-0328-2025

Naproxen Sodium tablets USP 550 mg – 100-count bottles

• Lot Number: 17231956
• Expiration Date: August 2025
• Recall Number: D-0346-2025

Nitroglycerin Sublingual Tablets 0.3 mg – 100-count bottle

• Lot Numbers: 17232361, 17232367
• Expiration Date: November 2025
• Recall Number: D-0331-2025

Nitroglycerin sublingual tablets 0.4 mg – 100-count carton

• Lot Numbers: 17232024, 17232071, 17232072
• Expiration Dates: August 2025 to September 2025
• Recall Number: D-0324-2025

Pravastatin Sodium tablets 20 mg – 500-count and 90-count bottles

• Lot Numbers: 17230810, 17230811, 17232501, 17232502
• Expiration Dates: March 2026 to November 2026
• Recall Number: D-0341-2025

Pravastatin Sodium tablets, USP, 20mg, 90-count bottle

• Lot number: 17230810
• Expiration date: Mar-26
• Recall Number: D-0349-2025

Pravastatin Sodium tablets, USP, 80mg, 90-count and 500-count bottles

• Lot numbers: 17221770, 17221774, 17231251, 17231262, 17232112, 17232133
• Expiration dates: Aug-25, May-26, Sep-26
• Recall Number: D-0350-2025

Pravastatin Sodium tablets 80 mg – 90-count bottle

• Lot Numbers: 17221771, 17230930, 17230931, 17231252, 17231274, 17231855, 17231916, 17231917, 17231945
• Expiration Dates: August 2025 to August 2026
• Recall Number: D-0325-2025

Prochlorperazine Maleate tablets 10 mg – 100-count bottle

• Lot Numbers: 17240254, 17240257
• Expiration Date: January 2026
• Recall Number: D-0338-2025

Propafenone Hydrochloride extended-release capsules 225 mg – 60-count bottle

• Lot Number: 17230819
• Expiration Date: March 2025
• Recall Number: D-0315-2025

Propafenone Hydrochloride extended-release capsules 325 mg – 60-count bottle

• Lot Number: 17230767
• Expiration Date: March 2025
• Recall Number: D-0316-2025

Propafenone Hydrochloride Extended-Release Capsules USP, 225mg, 60-count bottles

• Lot number: 17230819
• Expiration date: Mar-25
• Recall Number: D-0351-2025

Ranolazine extended-release tablets 1000 mg – 60-count bottle

• Lot Number: 17240040
• Expiration Date: December 2025
• Recall Number: D-0335-2025

Rosuvastatin tablets 40 mg – 30-count bottle

• Lot Numbers: 17240389, 17240390, 17240426, 17240427, 17240428, 17240778, 17241055, 17241074, 17241075, 17241091, 17241100
• Expiration Dates: February 2026 to June 2026
• Recall Number: D-0339-2025

Rufinamide tablets 200 mg – 120-count bottle

• Lot Numbers: 17231643, 17231644
• Expiration Date: July 2025
• Recall Number: D-0323-2025

Saxagliptin tablets 5 mg – 30-count and 90-count bottles

• Lot Numbers: 17232460, 17241194
• Expiration Dates: November 2025 to June 2026
• Recall Number: D-0332-2025

Saxagliptin tablets USP 2.5 mg – 30-count and 90-count bottles

• Lot Numbers: 17241788, 17241821, 17241822
• Expiration Date: September 2026
• Recall Number: D-0345-2025

Solifenacin Succinate tablets 5 mg – 30-count and 90-count bottles

• Lot Numbers: 17232395, 17232400
• Expiration Date: November 2025
• Recall Number: D-0333-2025

Solifenacin Succinate tablets 10 mg – 30-count and 90-count bottles

• Lot Number: 17230762
• Expiration Date: March 2025
• Recall Number: D-0317-2025

Teriflunomide tablets 14 mg – 30-count bottle

• Lot Number: 17232462
• Expiration Date: November 2025
• Recall Number: D-0334-2025

Voriconazole tablets 50 mg – 30-count bottle

• Lot Number: 17231045
• Expiration Date: April 2025
• Recall Number: D-0319-2025

Voriconazole tablets 200 mg – 30-count bottle

• Lot Numbers: 17230853, 17231271, 17231300, 17242050, 17231046, 17241156, 17241388, 17241800
• Expiration Dates: March 2025 to October 2026
• Recall Number: D-0318-2025

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