Recent Updates
Recently added Catalysts
RDY Negative Sentiment Score: 30/100

Dr. Reddy's Laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500 034, Telangana, India. CIN : L85195TG1984PLC004507 Tel : +91 40 4900 2900 Fax : +91 40 4900 2999 Email : mail@drreddys.com www.drreddys.co

Key Takeaway: Dr. Reddy's Laboratories has announced a voluntary nationwide recall of six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to issues with powder discoloration that affect potency. This recall was initiated after an accelerated stability test and customer complaints indicated decreased efficacy, which may lead to elevated Phenylalaninemia in patients. The product is distributed nationwide and affects various lots with expiration dates ranging from 2024 to 2026. Dr. Reddy's plans to notify distributors and customers, and consumers are advised to return the affected products.

Market Sentiment Analysis

CONCERNS & RISKS

  • Dr. Reddy's is voluntarily recalling their Sapropterin Dihydrochloride Powder due to powder discoloration, leading to reduced potency.
  • The recall could result in elevated Phenylalaninemia (Phe) levels in patients, posing significant health risks, including neurocognitive deficits.
  • The FDA is involved, indicating a serious issue with the product's safety and efficacy.

Full Press Release Details

National Stock Exchange of India Ltd. (Scrip Code:
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Please find enclosed a Press Release on "Dr.
Reddy's issues voluntary nationwide recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg due to Sub-potency".
This is for your information and records.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR
CONTACT
DR. REDDY'S LABORATORIES LTD. Investor relationS Media relationS
8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. RICHA PERIWAL richaperiwal@drreddys.com USHA IYER ushaiyer@drreddys.com
issues voluntary nationwide recall of
Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
FOR IMMEDIATE RELEASE Hyderabad India and Princeton,
NJ, US; April 23, 2024 - Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its
subsidiaries together referred to as "Dr. Reddy's"), today announced that it is voluntarily recalling six (6) lots of Sapropterin
Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased
potency. The issue was discovered during an accelerated stability test in addition to customer complaints.
Risk Statement: Reduced efficacy of the product
would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely
to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures.
Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart
Dr. Reddy's Laboratories Inc. has not received
any reports of adverse events related to this recall to date.
The product is indicated to reduce blood phenylalanine
(Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-)
responsive Phenylketonuria (PKU) and is packaged in individual packets, 30 per carton. The affected Sapropterin Dihydrochloride Powder
for Oral Solution 100mg lots include the following:
Product Name Lot Number Expiration date NDC Number
Javygtor (Sapropterin Dihydrochloride) Powder for Oral Solution 100 mg T2202812 07/2025 43598-097-30
T2204053 10/2025 43598-097-30
T2300975 02/2026 43598-097-30
T2300976 02/2026 43598-097-30
T2304356 08/2026 43598-097-30
Sapropterin Dihydrochloride Powder for Oral Solution 100 mg T2200352 12/2024 43598-477-30
Sapropterin Dihydrochloride Powder for Oral Solution
100 mg was distributed nationwide to wholesalers/retailers.
Reddy's Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns
of all recalled products. Anyone with an existing inventory of the product
being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride
Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who
have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase.
Consumers with questions regarding this recall can
contact Dr. Reddy's Laboratories Inc. by calling 866-733-3952 during office hours from 9 a.m. to 5 p.m. (EST) Monday through Friday.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or
using this drug product.
Adverse reactions or quality problems experienced
with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by
This recall is being conducted with the knowledge
of the U.S. Food and Drug Administration.
Please click here to see the full prescribing information
for Sapropterin Dihydrochloride Powder for Oral Solution 100 mg.
About Dr. Reddy's: Dr. Reddy's
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad,
India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of Good
Health Can't Wait', we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars
and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
Our major markets include - USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep
science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter
of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high
in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
Disclaimer: This press release may include statements
of future expectations and other forward-looking statements that are based on the management's current views and assumptions and
involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those
expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may",
"will", "should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking
statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general
economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels
and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition
and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the
impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets
addressed by our, and our customers', products and services to economic downturns as a result of natural disasters, epidemics, pandemics
or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings
with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements"
sections of our Annual Report on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update any information

Frequently Asked Questions

What product is being recalled by Dr. Reddy's?

Dr. Reddy's is recalling Sapropterin Dihydrochloride Powder for Oral Solution 100 mg.

Why is the Sapropterin product being recalled?

The recall is due to powder discoloration leading to reduced potency.

What should consumers do with the recalled product?

Consumers should return the product to their place of purchase and consult their physician.

How can consumers report issues with the product?

Consumers can report issues via the FDA's MedWatch Adverse Event Reporting program.

What are the risks associated with this recall?

The risks include elevated Phenylalaninemia levels, potentially causing serious health issues.

Last updated: Apr 23, 2024