The Recall Desk
ModerateFDA (Drugs)·D-0375-2019·Announced 2019-01-16

Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.

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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific issue is a physical deviation (thick suspension) without reported illnesses or injuries, fitting the Moderate severity criteria for minor labeling or quality errors without significant harm reports.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP, 125mg/5mL, due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 287,784 bottles of the medication, which is packaged in 60mL and 100mL containers. The product is a prescription-only antibiotic manufactured for Lupin Pharmaceuticals Inc. in Baltimore, MD, and manufactured by Lupin Limited in India.

The recall was initiated after product complaints were received indicating that the reconstituted suspension was observed to be thick. This physical characteristic deviation suggests a potential issue with the manufacturing process or product stability. The affected lots have expiration dates ranging from January 2019 to May 2019.

The recalled product was distributed nationwide within the United States. Patients and healthcare providers should stop using the affected lots of Cefdinir for Oral Suspension and contact their healthcare provider for alternative treatment options. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice to determine if they are affected.

The recalled product

Product
CEFDINIR (CEFDINIR)
Brand
CEFDINIR
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Antibiotic
Hazard
Affected units
287,784

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) Lot #: F700329
  • F700330
  • F700328
  • Exp. January 2019
  • F700544
  • F700545
  • F700668
  • F700669
  • F700670
  • Exp. March 2019
  • F700958
  • Exp. April 2019 b) Lot #: F700327
  • F700392
  • F700393
  • F700546
  • F700547
  • F700664
  • F700967
  • Exp. April 2019
  • F701106

UPCs (1)

  • 0368180723042

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Lupin 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 2 products in this recall →

Related recalls

Same brand · CEFDINIR

Same manufacturer · Lupin Pharmaceuticals Inc.

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Same hazard · cgmp deviation

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