The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0517-2023·Announced 2023-04-12

Glimepiride Tablets Recalled Due to Manufacturing Process Deviations

Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.

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 2/5 (Moderate).

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: FDA Class II classification indicates potential for adverse health consequences, but no illnesses, injuries, or hospitalizations are reported in the source. The hazard is manufacturing process compliance violations (cGMP deviations) without specific product defects described.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Glimepiride Tablets, USP, 2 mg, in 90-count bottles manufactured by Accord Healthcare, Inc., Durham, NC. The affected lots are: D0122K (expiration date 6/30/2024), I1422N (expiration date 9/30/2024), and I2721B (expiration date 1/31/2024), with NDC 68788-8095-9. A total of 17 bottles were distributed nationwide.

The recall was issued because current Good Manufacturing Practice (cGMP) deviations were identified at the manufacturing facility during an FDA inspection. These deviations relate to controls used in the manufacturing process.

Patients currently taking Glimepiride should contact their healthcare provider or pharmacist regarding this recall. Do not stop taking the medication without speaking to a healthcare professional first. Return any recalled bottles to the pharmacy where they were dispensed or contact Preferred Pharmaceuticals for further guidance.

Adverse events or product quality concerns should be reported to the FDA's MedWatch program.

The recalled product

Product
Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Antidiabetic medication
Hazard
Affected units
17

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 (6)

  • Lot: D0122K
  • Exp. Date: 6/30/2024
  • Lot: I1422N
  • Exp. Date: 9/30/2024
  • Lot: I2721B
  • Exp. Date: 1/31/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, Inc. 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 17 products in this recall →

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