The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1511-2014·Announced 2014-08-13

Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations

Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.

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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Caraco Pharmaceutical Laboratories, Ltd. is recalling Cephalexin Capsules, USP, 500 mg, packaged in 100-count and 500-count bottles. The affected products are prescription-only and were manufactured by Sun Pharmaceutical Ind. Ltd. in India.

The recall was initiated because the products were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices (CGMP deviations). The affected lots were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should stop using the affected Cephalexin Capsules and contact their healthcare provider for a replacement or alternative treatment. The specific lot numbers and expiration dates are detailed in the official recall notice.

The recalled product

Product
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Manufacturer
Caraco Pharmaceutical Laboratories, Ltd.
Category
Drug — Antibiotic
Hazard

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)

  • Lot #: a) AGL0058B
  • AGL0059B
  • AGL0060B
  • AGL0061B
  • Exp 06/14
  • AGL0062B
  • AGL0063B
  • AGL0064B
  • Exp 07/14
  • AGL0083B
  • AGL0084B
  • AGL0085B
  • AGL0086B
  • AGL0087B
  • AGL0088B
  • AGL0089B
  • AGL0090B
  • Exp 08/14
  • AGL0120B
  • AGL0121B

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Caraco Pharmaceutical Laboratories, Ltd. 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 →

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