Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Affected NDC
68462-0295-01
Compare with the code on your package — it is the most precise check available.
Drug: Verapamil
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 |
|---|---|---|---|---|
| Trandolapril and Verapamil Hydrochloride NDC 68462-0295 |
TRANDOLAPRIL 2 mg/1; VERAPAMIL HYDROCHLORIDE 180 mg/1 | Tablet, Film Coated, Extended Release Oral |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-295-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1095-2023 · 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.
Other Verapamil recalls
See all
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class II · Moderate risk
Verapamil HCL
cGMP deviations: Temperature abuse
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2023 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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