RecallRadar

FDA Drug recall D-0598-2018

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc

On 2018-03-21 the FDA classified a Class III recall of Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc by Dr Reddy S Laboratories, citing failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0598-2018
ClassificationClass III
Statusterminated
Initiated2018-03-08
Published2018-03-21
Last updated2026-09-13 11:52 UTC
CompanyDr Reddy S Laboratories
DistributionUS

Product

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90

Reason

Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

Identifiers

code_infoLot # MGEC

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0598-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.