Glimepiride Tablets Recall Due to Manufacturing Quality Deviations
Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.
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: FDA Class II recall initiated due to manufacturing quality deviations. No illnesses, injuries, or adverse events have been reported in the source material, and the hazard is administrative/preventive rather than based on documented patient harm.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Glimepiride Tablets USP, 4 mg manufactured by Accord Healthcare, Inc., Durham, NC. The recalled product consists of 15 bottles with lot numbers H1221Z, I0121J, and J0622X, with an expiration date of 10/31/2023. The affected medication was distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations identified at Accord Healthcare following an FDA inspection. cGMP deviations indicate that manufacturing processes, quality controls, or facility standards did not meet federal requirements for drug production. The source documentation does not specify the particular nature of the deviations or whether any adverse effects have been reported in patients.
The recalled product
- Product
- Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antidiabetic medication
- 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 (4)
- Lot: H1221Z
- I0121J
- J0622X
- Exp 10/31/2023.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27