The Recall Desk
ModerateFDA (Drugs)·D-0894-2023·Announced 2023-07-12

Tizanidine tablets recalled nationwide for failed stability specifications

Preferred Pharmaceuticals is recalling 541 bottles of Tizanidine 4mg tablets nationwide due to failed stability specifications. Consumers with affected lot numbers should contact their pharmacist or healthcare provider.

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: This is a Class II recall for a manufacturing quality issue (failed stability specifications). No illnesses, injuries, or hospitalizations are reported in the source material. The recall is precautionary to prevent potential loss of drug potency or quality degradation, which constitutes a voluntary precautionary recall typical of Moderate severity.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Tizanidine Hydrochloride 4mg tablets due to failed stability specifications. The recall affects 541 bottles distributed nationwide, including 20-count, 30-count, 60-count, 90-count, and 120-count bottles.

The affected lot numbers are: H1621S, H2321C, H0421B, H1721E, H1921T, H3121M, and H2021G. All affected lots have a December 31, 2023 expiration date. Consumers can identify affected medications by these lot numbers on the bottle label.

Patients should not use medication from these lots. Contact your pharmacist or healthcare provider if you have a prescription filled with an affected lot number. Do not dispose of the medication yourself; return it to your pharmacy for proper disposal.

The recalled product

Product
TIZANIDINE (TIZANIDINE)
Brand
TIZANIDINE
Manufacturer
Preferred Pharmaceuticals, Inc.
Hazard
  • stability-failure

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 (8)

  • Lot#: a) H1621S
  • Exp: 12/31/2023
  • b) H2321C
  • c) H0421B
  • d) H1721E
  • H1921T
  • H3121M
  • e) H2021G

Distribution

Distributed nationwide across the United States.