Home / Recalls / The Harvard Drug Group LLC / D-0493-2026

D-0493-2026 Class II Ongoing

Recalled by The Harvard Drug Group LLC — Dublin, OH

Recall Details

Product Type
Drugs
Report Date
April 29, 2026
Initiation Date
April 9, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,238 5 x 10 unit dose cartons

Product Description

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

Reason for Recall

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

Distribution Pattern

Nationwide in the USA

Code Information

Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026

Other recalls by The Harvard Drug Group LLC

  • D-0485-2026 Class II — Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 (March 24, 2026)
  • D-0383-2026 Class II — Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), R (February 17, 2026)
  • D-0031-2026 Class II — Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Pa (October 10, 2025)
  • D-0030-2026 Class II — Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, (October 10, 2025)
  • D-0507-2025 Class II — Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx (June 19, 2025)
  • D-0508-2025 Class II — Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged (June 19, 2025)
  • D-0878-2023 Class II — Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, (June 16, 2023)
  • D-0570-2023 Class III — Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets p (April 24, 2023)
  • D-0432-2023 Class II — Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Onl (February 23, 2023)
  • D-0649-2022 Class II — PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 bli (February 28, 2022)