The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1510-2014·Announced 2014-08-13

Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations

Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with 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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing deviations rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Caraco Pharmaceutical Laboratories, Ltd. is recalling Cephalexin Capsules, USP, 250 mg, in 100-count and 500-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically because the active pharmaceutical ingredients (APIs) were not manufactured with good manufacturing practices.

The affected products are prescription-only and were distributed nationwide and in Puerto Rico. The recall includes specific lot numbers and expiration dates ranging from September 2014 to September 2015. The products were manufactured by Sun Pharmaceutical Ind. Ltd. in India.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. No specific adverse health consequences or illnesses have been reported in the source text.

The recalled product

Product
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), 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) AGL0098B
  • AGL0099B
  • AGL0100B
  • AGL0101B
  • Exp 09/14
  • AGM0073B
  • AGM0074B
  • Exp 04/15
  • AGM0125B
  • AGM0126B
  • Exp 07/15
  • AGM0158B
  • Exp 09/15
  • b) AGL0092A
  • AGL0093A
  • AGL0094A
  • AGL0095A
  • AGL0096A
  • AGL0097A
  • AGL0102A

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 →

Related recalls

Same manufacturer · Caraco Pharmaceutical Laboratories, Ltd.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls