Teva Recalls Mesalamine Tablets Due to Failed Dissolution Testing
Teva Pharmaceuticals is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets because stability testing revealed out-of-specification dissolution results.
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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
Teva Pharmaceuticals USA is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets, USP 1.2 gram. The product is a prescription-only medication distributed nationwide in the U.S. and Puerto Rico. The recall was initiated because out-of-specification dissolution results were obtained during stability testing.
The affected product is manufactured by Actavis Laboratories, FL, Inc., and distributed by Actavis Pharma Inc. The specific NDC for the recalled product is 0591-2245-22. The recall covers multiple lot numbers with expiration dates ranging from December 2020 to June 2022.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected medication.
The recalled product
- Product
- MESALAMINE (MESALAMINE)
- Brand
- MESALAMINE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Drug
- Affected units
- 133,829
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 (20)
- Lot #s: 1342498A
- Exp. 12/2020
- 1342499A
- Exp. 01/2021
- 1354638A
- Exp. 03/2021
- 1354639A
- 1358274A
- 1358448A
- 1364618A
- 1369884A
- Exp. 05/2021
- 1366195A
- 1369885A
- 1373570A
- Exp. 06/2021
- 1373571A
- Exp. 07/2021
- 1388571A
- Exp. 01/2022
UPCs (1)
- 0305912245229
Distribution
Distributed nationwide across the United States.
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