FDAClass IIMarch 10, 2021

Progesterone Capsules recall: Failed Dissolution

Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.

Why was Progesterone Capsules recalled?

Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch # 1399851P1, Exp 02/2021

Product
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
16,449 bottles
Distribution
Nationwide in the USA
Recall date
March 10, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls