Nifedipine Extended-Release Tablets Recall for Failed Dissolution
The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a dissolution specification failure discovered during stability testing. The source text does not report any illnesses, injuries, or hospitalizations. Dissolution failures indicate a quality control issue but do not meet the threshold for High severity without evidence of actual harm or high-risk pathogens.
Plain-English summary
The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets, USP 30 mg because the product failed to meet dissolution specifications during routine stability testing. The tablets are available in two package sizes: 100-count unit dose cartons (NDC 0904-7080-61) and 50-count unit dose cartons (NDC 0904-7080-06).
The affected lots are N00418 (expiration 09/2022) and N00417 (expiration 09/2022). A total of 504 cartons of 50-count packages and 372 cartons of 100-count packages were distributed to Ohio and New Jersey. The product was distributed by Ingenus Pharmaceuticals, LLC in Orlando, Florida and Major Pharmaceuticals in Livonia, Michigan.
Patients currently taking the recalled nifedipine should consult their healthcare provider or pharmacist before discontinuing the medication or switching to an alternative product. The FDA has classified this as a Class II recall.
The recalled product
- Product
- NIFEDIPINE (NIFEDIPINE)
- Brand
- NIFEDIPINE
- Manufacturer
- The Harvard Drug Group
- Hazard
- dissolution-failure
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: a)N00418 Exp. 09/2022
- b) N00417 Exp. 09/2022
UPCs (1)
- 0309047080618
Distribution
Distributed in 2 states:
- NJ
- OH
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