Defective container; inadequately sealed blister packaging.
Defective container; inadequately sealed blister packaging.
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance. Notification method: Letter
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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.. Generic: MIDODRINE HYDROCHLORIDE; Brand: MIDODRINE HYDROCHLORIDE. Reason: Defective container; inadequately sealed blister packaging.. Classification: Class II. Quantity: 8892 cartons. Distribution: Nationwide US.
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Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Stability Data Does Not Support Expiry Date.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution