Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Aug 28, 2017 (9 years ago)

Propafenone Hydrochloride tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed moisture limits: Out of specification for moisture content.

Cause type: Failed specification

A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.

What was recalled

Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10

Affected NDC 63739-0509-10

Compare with the code on your package — it is the most precise check available.

Drug: Propafenone

Recalling firm
Mckesson Packaging Services
NDC code
63739-509-10
Origin
NC, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1128-2017 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Propafenone recalls

See all
Class II · Moderate risk

Propafenone HCL

Labeling: Label Mixup: PROPAFENONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 00185004109, Pedigree: AD54549_7, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-966-2014

Other recalls by Mckesson Packaging Services

All 2017 recalls
Class III · Low risk

Diltiazem CD

Failed Dissolution Specifications. High dissolution results were obtained during stability testing.

Terminated Dissolution failure Mckesson Packaging Services NDC 63739-284-10 D-0715-2018