A report details "deviations" during manufacturing of more than 135,000 packages, which could possibly contribute to other health problems.
High blood pressure affects nearly 50% of all American adults, an estimated 46.7%—and new high blood pressure guidelines, released earlier this month by the American Heart Association and the American College of Cardiology, now say there’s another reason to take it seriously: hypertension could affect your brain health, potentially leading to cognitive decline and dementia.
But there are practical, everyday choices you can make to address this major health concern, such as limiting salt intake, exercising to manage stress, and following a heart-healthy diet. The new guidelines also say “many people with high blood pressure, especially those who have Type 2 diabetes, obesity or kidney disease” may benefit from being on “more than one medication” to treat it.
However, two heart-helping medications were recently named in several nationwide recalls announced by the U.S. Food and Drug Administration (FDA) this month. Altogether, 135,788 total packages of these drugs are reportedly affected. Each of the following has been individually classified as a Class II recall, meaning the FDA has deemed each product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Multiple dosages of one type
The first medication, Carvedilol, is named in three recent enforcement reports: one released on August 12, another on August 14, and a third posted on August 21. Between the three events, 114,660 containers have been recalled in the U.S.
According to the Mayo Clinic, Carvedilol is a generic for a name brand such as Coreg. Mayo adds this beta blocker may be prescribed to treat hypertension (also known as high blood pressure), to prevent “further worsening” of congestive heart failure, or for left ventricular dysfunction after a heart attack.
The FDA reports list a problem with CGMP Deviations as the reason for recall. CGMP is an abbreviation for “Current Good Manufacturing Practice,” which the agency furthers describes as an way of ensuring pharmaceutical quality for Americans.
Specifically, each recall mentions different issues concerning “N-Nitroso Carvedilol Impurity-1” results. The FDA provides recommended “acceptable intake” limits for nitrosamine drugs “based on a safety assessment that includes evaluation of the mutagenic and carcinogenic potential of the impurity and represents the level at or below which FDA has determined that the impurity or impurities would not pose a safety concern for patients taking the drug product,” suggesting potential concerns for either DNA mutations or cancer-causing properties.
The product details are:
Carvedilol Tablets, USP, 12.5 milligrams (mg)
- 500 Tablets per carton
- Rx Only
- Lot numbers: 17241257, 17241258, 17241279
- Expiration Date: 06/2026
- Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India
- Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430
- NDC 68462-164-05
- Recall reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- 17,496 bottles
Carvedilol Tablets, USP, 25 milligrams (mg)
- 500 Tablets per carton
- Rx Only
- Lot numbers: 17241213, 17241215, 17241224
- Expiration Date: 06/2026
- Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India
- Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430
- NDC: 68462-165-05
- Recall reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- 14,976 bottles
Carvedilol Tablets, USP, 3.125 milligrams (mg)
- Packaged as: a) 500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01
- Rx only
- Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20 [Editor’s note: The FDA’s report does not list the final two numbers of this expiration date]; b) 19242272, Exp: 5/31/2026
- Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India.
- Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
- Recall reason: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- 44,328 bottles
Carvedilol Tablets, USP, 12.5 milligrams (mg)
- 500-count bottle
- Rx only
- Lot number: 19243202
- Expiration Date: 7/31/2026
- Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India.
- Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430
- NDC: 68462-164-05
- Recall reason: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- 6,432 bottles
Carvedilol Tablets, USP, 25 milligrams (mg)
- 500-count bottle
- Rx only
- Lot number: 19243104
- Expires: 7/31/2026
- Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India.
- Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
- NDC: 68462-165-05
- Recall reason: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- 4,800 bottles
Carvedilol Tablets USP, 12.5 milligrams (mg)
- 100- Tablets, (10×10) cartons
- Rx Only
- Lot number: T05693
- Expiration Date: 03/2026
- Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA
- NDC: 0904-7307-61
- Recall reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- 26,628 cartons
Another blood pressure drug recalled
In an August 12 enforcement report, the FDA also alerted the public that 21,128 bottles of Metoprolol Tartrate Tablets had been recalled nationwide.
The Cleveland Clinic notes Metoprolol may serve as a generic for name brands like Lopressor, typically prescribed to lower blood pressure. The drug may also prevent chest pain or additional damage post-heart attack.
Similar to the recalls listed above, CGMP Deviations and a nitrosamine level above “acceptable daily intake” appear to be the causes of concern. States the report’s Reason for Recall section: “CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.”
Metoprolol Tartrate Tablets, USP, 50 milligrams (mg)
- 1,000 Tablets
- Rx Only
- Batch Numbers and Expiration Dates: R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26
- Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh
- Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217
- NDC: 69367-354-10
- Recall reason: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- 16,672 1000-count bottles
Metoprolol Tartrate Tablets, USP, 100 milligrams (mg)
- 1,000 Tablets
- Rx Only
- Batch Numbers and Expiration Dates: Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
- Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh
- Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217
- NDC: 69367-355-10
- Recall reason: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- 4,456 1000-count bottles
It’s worth noting that this isn’t the first time this year one of the recalling firms, Glenmark Pharmaceuticals Inc., has seen issues with Carvedilol tablets. In May, we reported that more than 732,000 bottles of the medication had been recalled.
Additionally, the other Carvedilol-recalling firm—Harvard Drug Group LLC doing business as Major Pharmaceuticals and Rugby Laboratories—was named in an anxiety medication recall earlier this year.
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