Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls
15 official recalls and safety alerts involving Harvard Drug Group LLC dba Major Pharmaceuticals and… since 2023-06, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Harvard Drug Group LLC dba Major Pharmaceuticals and… or the relevant agency.
- 2025-10-15
USThe Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only,…
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- 2025-09-17
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister…
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was…
- 2025-08-27
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by…
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Product was distributed nationwide within the United States.Official notice → - 2025-04-23
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only,…
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
- 2025-04-09
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only,…
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice → - 2025-02-26
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The…
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide U.S. and Puerto ricoOfficial notice → - 2025-02-12
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10…
Failed Dissolution Specifications.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice → - 2025-02-05
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC…
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice → - 2024-11-27
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive,…
Failed Impurity/Degradation Specifications
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice → - 2024-11-20
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet…
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the US.Official notice → - 2024-07-10
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton,…
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide. No foreign consignees.Official notice → - 2024-02-21
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680,…
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…The product was distributed nationwide within the United States.Official notice → - 2023-12-27
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC…
Failed Content Uniformity Specifications
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice → - 2023-11-29
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY…
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice → - 2023-06-28
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's…
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →