The Recall Desk
SevereFDA (Drugs)·D-0326-2021·Announced 2021-04-14

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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.