FDA Drug recall D-0383-2026

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals,…

• FDA Drug
• Class II
• ongoing
• Published 2026-03-11

On 2026-03-11 the FDA classified a Class II recall of Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals,… by The Harvard Drug Group, citing defective container; inadequately sealed blister packaging.

Read the official FDA Drug notice

Product

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

Reason

Defective container; inadequately sealed blister packaging.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Other recalls by The Harvard Drug Group

• Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMA…
  FDA Drug · Class II · 2026-07-01 · The Harvard Drug Group
• Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distribut…
  FDA Drug · Class II · 2026-04-29 · The Harvard Drug Group
• Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
  FDA Drug · Class II · 2026-04-22 · The Harvard Drug Group
• Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indian…
  FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
• Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapo…
  FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group

All The Harvard Drug Group recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0383-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.