CLASS II ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
Carvedilol Tablets USP, 12.5 mg recalled by The Harvard Drug Group
The Harvard Drug Group is recalling Carvedilol Tablets USP, 12.5 mg, distributed nationwide in the US. The recall was initiated on 20 Aug 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0594-2025
- FDA event ID
- 97449
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Brand
- Carvedilol
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2025
- FDA classified
- 21 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 20 Aug 2025 | Recall initiated by company | |
| 21 Aug 2025 | Classified by FDA | +1 day |
| 27 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Where it was distributed
Product was distributed nationwide within the United States.
Questions about this recall
Why was it recalled?
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Which lots are affected?
Lot #: T05693, Exp. Date 03/2026
Where was it sold?
Product was distributed nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Carvedilol recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a) recalledCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |