The Recall Desk
LowFDA (Drugs)·D-0721-2016·Announced 2016-02-24

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

Dr. Reddy's Laboratories is recalling 11,123 bottles of Paricalcitol capsules nationwide because the capsules have broken and leaked.

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. The issue is physical breakage and leakage rather than a high-risk contamination or mislabeling of a common allergen.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 11,123 bottles of Paricalcitol Capsules, 4 mcg, 30 capsules per bottle. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in Bachupally, India, and distributed nationwide.

The recall was initiated due to reports of breakage and leakage of the Paricalcitol capsules. The affected lots are C404440 (Exp 04/2016), C404946 (Exp 05/2016), and C505704 (Exp 07/2017). The agency has classified this as a Class III recall.

Consumers and healthcare providers should stop using the affected capsules and contact their pharmacist or Dr. Reddy's Laboratories for further instructions.

The recalled product

Product
PARICALCITOL (PARICALCITOL)
Brand
PARICALCITOL
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
11,123

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 (6)

  • Lot #s: C404440
  • Exp 04/2016
  • C404946
  • Exp 05/2016
  • C505704
  • Exp 07/2017

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 →

Related recalls

Same brand · PARICALCITOL

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · capsule breakage

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