The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories appears in FDA public data with 24 recalls — including 4 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0013-2026, Class II) was initiated on September 12, 2025.
Summary
- Total Recalls
- 24 (4 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0013-2026 | Class II | Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Onl | September 12, 2025 |
| D-0011-2026 | Class II | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Onl | September 12, 2025 |
| D-0012-2026 | Class II | Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Onl | September 12, 2025 |
| D-0009-2026 | Class II | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, | September 12, 2025 |
| D-0010-2026 | Class II | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only | September 12, 2025 |
| D-0625-2025 | Class II | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister | September 2, 2025 |
| D-0624-2025 | Class II | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blist | September 2, 2025 |
| D-0594-2025 | Class II | Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by | August 20, 2025 |
| D-0366-2025 | Class II | ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx onl | April 14, 2025 |
| D-0304-2025 | Class III | Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only | March 4, 2025 |
| D-0221-2025 | Class II | Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 u | January 30, 2025 |
| D-0228-2025 | Class II | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The | January 21, 2025 |
| D-0226-2025 | Class II | Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, T | January 21, 2025 |
| D-0227-2025 | Class II | Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The | January 21, 2025 |
| D-0212-2025 | Class II | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) ND | January 13, 2025 |
| D-0050-2025 | Class II | Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, | November 7, 2024 |
| D-0049-2025 | Class II | Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, | November 7, 2024 |
| D-0045-2025 | Class III | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceut | November 5, 2024 |
| D-0584-2024 | Class II | Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carto | June 18, 2024 |
| D-0324-2024 | Class II | HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680 | February 9, 2024 |