The Recall Desk
ModerateFDA (Drugs)·D-0482-2023·Announced 2023-04-05

Glimepiride tablet recall due to manufacturing practice deviations

Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.

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 FDA Class II recall involves no reported illnesses or injuries and concerns manufacturing process deviations rather than confirmed product contamination. Voluntary precautionary recalls are classified as Moderate per the rubric.

Plain-English summary

Direct Rx, located in Dawsonville, Georgia, initiated a voluntary recall of Glimepiride, USP, 4 mg tablets on March 13, 2023. The recall was issued due to deviations from current Good Manufacturing Practice (cGMP) standards during the manufacturing process. The affected product was distributed nationwide in the United States.

The recall affects specific lot numbers of Glimepiride 4 mg tablets packaged in two sizes: 30-count bottles and 90-count bottles. A total of 7 bottles of the 30-count size and 395 bottles of the 90-count size were distributed. Multiple lot numbers are included in this recall, each with different expiration dates ranging from October 2023 through July 2024.

Consumers should stop using affected lots immediately and consult their healthcare provider or pharmacist regarding their medication supply. Patients should not discontinue their prescribed medications without consulting a healthcare professional. The U.S. Food and Drug Administration has classified this as a Class II recall. The recall was terminated on June 17, 2024.

The recalled product

Product
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug — Oral Tablet / Prescription
Hazard
  • manufacturing-deviation

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: 13DE2111
  • exp 3/31/2024 b) [90 count bottles] Lot
  • expiry: 17NO2116
  • exp 1/31/2024
  • 27JA2234
  • exp 4/30/2024
  • 02MA2218
  • exp 6/30/2024
  • 12MY2211
  • exp 7/31/2024
  • 13JY2107
  • exp 10/31/2023
  • 15AP2221
  • 17AU2110
  • 20SE2108
  • 23JU2115
  • 28JY2101
  • 30JY2101
  • 05JA2212

Distribution

Distributed nationwide across the United States.

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