The Recall Desk
ModerateFDA (Drugs)·D-0376-2019·Announced 2019-01-16

Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to product complaints indicating 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation (thick suspension) without reported harm, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where injury has not been reported.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in 60mL and 100mL bottles. The recall involves 287,784 bottles distributed nationwide within the United States. The product is a prescription-only medication manufactured by Lupin Limited in India for Lupin Pharmaceuticals Inc. in Baltimore, MD.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, product complaints were received indicating that the reconstituted suspension was observed to be thick. The affected lots include specific lot numbers with expiration dates ranging from January 2019 to April 2019.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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 #: F700343
  • F700344
  • F700345
  • F700346
  • F700347
  • F700376
  • F700377
  • F700415
  • F700146
  • F700417
  • F700418
  • Exp. Jan 2019
  • F700419
  • F700420
  • F700492
  • F700493
  • F700508
  • F700665
  • Exp. February 2019
  • F700784

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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