The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0481-2023·Announced 2023-04-05

FDA Recalls Glimepiride Tablets Due to Manufacturing Quality Violations

Direct Rx is voluntarily recalling Glimepiride 2 mg tablets nationwide due to manufacturing practice violations. The recall affects multiple lot numbers of 30-count and 90-count bottles distributed across the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall due to manufacturing practice violations (cGMP deviations). No reported illnesses or injuries. Manufacturing quality control failures represent a potential risk of harm to patients, warranting High severity despite absence of confirmed patient harm.

Plain-English summary

Direct Rx, based in Dawsonville, Georgia, is recalling Glimepiride, USP, 2 mg tablets nationwide. The recall affects 12 bottles of 30-count packages (NDC 61919-0488-30) and 253 bottles of 90-count packages (NDC 61919-0448-90). Multiple lot numbers with expiration dates ranging from September 2023 through July 2024 are included.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations in the manufacturing process. On March 24, 2023, the FDA classified this as a Class II recall, and Direct Rx began the recall on March 13, 2023, as a voluntary, firm-initiated action.

The affected tablets were distributed nationwide throughout the United States. Consumers who have received this medication should contact their pharmacist or healthcare provider with questions about their supply. Consumers should not use recalled lots and should consult their healthcare provider about obtaining replacement medication.

The recalled product

Product
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard

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)

  • a) [30 count bottles] Lot
  • expiry: 21JU2112
  • exp 9/30/2023 b) [90 count bottles] Lot
  • expiry: 22DE2113
  • exp 1/31/2024
  • 27JA2235
  • exp 3/31/2024
  • 05AP2224
  • exp 7/31/2024
  • 06AU2104
  • 08JU2215
  • exp 9/30/2024
  • 209AU2109
  • 15JU2113
  • exp 9/30/2023
  • 21FE2217
  • exp 4/30/2024
  • 21OC2115
  • exp 2/29/2024
  • 23JY2144

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Direct Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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