The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

FDA Regulatory Profile

Summary

Total Recalls
24 (4 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0013-2026Class IIMajor ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx OnlSeptember 12, 2025
D-0012-2026Class IIMajor ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx OnlSeptember 12, 2025
D-0010-2026Class IIMajor ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx OnlySeptember 12, 2025
D-0009-2026Class IIMajor ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, September 12, 2025
D-0011-2026Class IIMajor ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx OnlSeptember 12, 2025
D-0624-2025Class IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blistSeptember 2, 2025
D-0625-2025Class IISulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blisterSeptember 2, 2025
D-0594-2025Class IICarvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed byAugust 20, 2025
D-0366-2025Class IIChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx onlApril 14, 2025
D-0304-2025Class IIITolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx onlyMarch 4, 2025
D-0221-2025Class IIPotassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 uJanuary 30, 2025
D-0227-2025Class IILorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, TheJanuary 21, 2025
D-0228-2025Class IILorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, TheJanuary 21, 2025
D-0226-2025Class IILorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, TJanuary 21, 2025
D-0212-2025Class IIDuloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDJanuary 13, 2025
D-0049-2025Class IIGuaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive,November 7, 2024
D-0050-2025Class IIGuaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, November 7, 2024
D-0045-2025Class IIIHydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet PharmaceutNovember 5, 2024
D-0584-2024Class IIVenlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one cartoJune 18, 2024
D-0324-2024Class IIHydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680February 9, 2024