Teva Recalls Mesalamine Tablets Due to Dissolution Test Failures
Teva Pharmaceuticals USA is recalling 3,695 bottles of Mesalamine Delayed-Release Tablets because stability testing showed low dissolution results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, which is a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct toxicological threat like contamination.
Plain-English summary
Teva Pharmaceuticals USA is recalling 3,695 bottles of Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count. The product is distributed nationwide in the USA. The specific lot affected is 1342500A, with an expiration date of 10/2020.
The recall was initiated because a low out-of-specification dissolution result was observed during stability testing. This indicates that the tablets may not dissolve as required by the United States Pharmacopeia (USP) standards.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- MESALAMINE (MESALAMINE)
- Brand
- MESALAMINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,695
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)
- Lot #: 1342500A
- Exp 10/2020
UPCs (1)
- 0305912245229
Distribution
Distributed nationwide across the United States.
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