Alembic Pharmaceuticals Recalls Telmisartan Tablets Due to Labeling Error
Alembic Pharmaceuticals is recalling 12,288 bottles of Telmisartan 20 mg tablets due to a label mixup. The product was distributed nationwide in the United States.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4. Since no specific deaths or injuries are reported in the text, the score is set to 4 (Severe) rather than 5 (Critical).
Plain-English summary
Alembic Pharmaceuticals Limited is recalling 12,288 bottles of Telmisartan Tablets, USP 20 mg. The recall is being conducted due to a labeling error, specifically a label mixup. The affected product is a prescription-only medication manufactured by Alembic Pharmaceuticals Limited and distributed nationwide within the United States.
The specific lot number for the recalled product is 1905005661, with an expiration date of March 2022. The product is identified by NDC 62332-087-30. Telmisartan is an angiotensin 2 receptor blocker used to treat high blood pressure.
Consumers who have this specific lot of Telmisartan should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- TELMISARTAN (TELMISARTAN)
- Brand
- TELMISARTAN
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 12,288
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 #: 1905005661
- Exp March 2022
UPCs (3)
- 0362332087303
- 0362332088300
- 0362332089307
Distribution
Distributed nationwide across the United States.
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