Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01
Affected NDC
16714-0826-01
Compare with the code on your package — it is the most precise check available.
Drug: Propafenone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| propafenone hydrochloride NDC 16714-0826 |
325 mg/1 | Capsule, Extended Release Oral |
Northstar Rx LLC | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 16714-826-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0352-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Propafenone recalls
See all
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 325mg
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules 225mg
CGMP Deviations
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
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.
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2025 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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