April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Mad
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx O
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactu
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pitha
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limi
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited,
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pi
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pitham
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madh
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhy
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Mad
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx On
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceut
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceu
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur
Hazard: CGMP Deviations
April 16, 2025DrugsFDA
ASEGUA THERAPEUTICS LLC recalls Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua The
Hazard: Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
April 16, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC
Hazard: Cross Contamination
April 16, 2025DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, ND
Hazard: Cross Contamination
April 16, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydu
Hazard: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
April 9, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceut
Hazard: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
April 9, 2025DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutica
Hazard: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
April 9, 2025DrugsFDA
Amerisource Health Services LLC recalls Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per
Hazard: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
April 9, 2025DrugsFDA
BIOCON PHARMA INC recalls Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 088
Hazard: Failed dissolution specifications: lower than specifications
April 9, 2025DrugsFDA
Imprimis NJOF, LLC recalls Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15
Hazard: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.