The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-238-2013·Announced 2013-04-10

Dr. Reddy's Recalls Tizanidine Tablets Due to Illegible Labeling

Dr. Reddy's Laboratories is recalling Tizanidine Tablets because bottle labels may be missing the product strength and other printing details.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to packaging/labeling issues.

Plain-English summary

Dr. Reddy's Laboratories is voluntarily recalling Tizanidine Tablets USP, 4 mg, 150-count bottles. The recall is due to a labeling defect where the bottle labels may not contain the product strength or other printing details, making them illegible.

The affected product is Tizanidine Tablets USP, 4 mg, manufactured by Dr. Reddy's Laboratories Limited in India. The specific lot numbers involved are C208625, C208984, C209113, C209369 (Exp 09/15), and C209680 (Exp 10/15). The NDC number is 55111-180-15. A total of 117,546 bottles were distributed nationwide and in Puerto Rico.

Consumers should check their medication bottles for these specific lot numbers and expiration dates. If the label is illegible or missing the strength information, they should contact their pharmacist or Dr. Reddy's Laboratories for a replacement or refund. This recall is classified as Class III by the FDA, indicating a remote probability of adverse health consequences.

The recalled product

Product
TIZANIDINE (TIZANIDINE)
Brand
TIZANIDINE
Manufacturer
Dr. Reddy'S Laboratories
Category
Drug — Prescription Drug
Hazard
Affected units
117,546

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 (7)

  • Lot #: C208625
  • C208984
  • C209113
  • C209369
  • Exp 09/15
  • and C209680
  • Exp 10/15.

UPCs (2)

  • 0355111180104
  • 0355111179108

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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