The Recall Desk
LowFDA (Drugs)·D-0719-2016·Announced 2016-02-24

Dr. Reddy's Recalls Paricalcitol Capsules Due to Breakage and Leakage

Dr. Reddy's Laboratories is recalling 9,155 bottles of Paricalcitol capsules nationwide due to reports of breakage and leakage.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for packaging or cosmetic defects.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 9,155 bottles of Paricalcitol Capsules, 1 mcg, 30 capsules per bottle. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India and distributed nationwide.

The recall was initiated due to reports of breakage and leakage of the Paricalcitol capsules. The affected lots include C404795, C404796, C404797, C406272, C406273, C406274, C406518, C409586, C409587, C409588, C501835, C501836, C501837, C503797, C503798, C505009, C505568, and C505569, with expiration dates ranging from May 2016 to July 2017.

Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. The FDA has classified this as a Class III recall, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product
PARICALCITOL (PARICALCITOL)
Brand
PARICALCITOL
Affected units
9,155

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 #s: C404795
  • C404796
  • C404797
  • Exp 05/2016
  • C406272
  • C406273
  • C406274
  • C406518
  • Exp 07/2016
  • C409586
  • C409587
  • Exp 11/2016
  • C409588
  • Exp 12/2016
  • C501835
  • C501836
  • C501837
  • Exp 02/2017
  • C503797
  • C503798

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Dr. Reddy's Laboratories, 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 3 products in this recall →