-
Recalled Dr. Reddy’s Imatinib Mesylate Tablets 100 mg -
Recalled Dr. Reddy’s Imatinib Mesylate Tablets 100 mg -
Recalled Dr. Reddy’s Imatinib Mesylate Tablets 400 mg -
Recalled Dr. Reddy’s Imatinib Mesylate Tablets 400 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 50 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 50 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 75 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 75 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 100 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 100 mg -
Recalled Dr. Reddy’s Pregabalin Capsules 150 mg -
Recalled Dr. Reddy’s Sevelamer Carbonate Tablets 800 mg -
Recalled Dr. Reddy’s Sevelamer Carbonate Tablets 800 mg -
Recalled Dr. Reddy’s Tadalafil Tablets 5 mg -
Recalled Dr. Reddy’s Tadalafil Tablets 5 mg -
Recalled Dr. Reddy’s Tadalafil Tablets 20 mg -
Recalled Dr. Reddy’s Tadalafil Tablets 20 mg
The products are prescription medications that were labeled and distributed by Dr. Reddy’s for institutional use only. The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers. The packaging of the products is not child resistant and can pose a risk of poisoning if the contents are swallowed by young children.
About 21,400
Dr. Reddy’s toll-free at 888-375-3784 from 8 a.m. to 8 p.m. ET Monday through Friday, or online at www.drreddys.com and click on “Recall” for more information. Report incidents related to children accessing or ingesting these prescription medications to www.SaferProducts.gov. Report adverse events, medication errors, and quality problems related to the use of these products to FDA’s MedWatch Adverse Event Reporting Program either online at www.fda.gov/medwatch/report.htm, download the form at www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and submit by regular mail, and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.
Recall Details
This recall involves blister packages of prescription medications. The name and strength of the medication, “For Institutional Use only,” “Rx Only,” lot number and expiration date are printed on the outside of the package as well as on the individual blister units. The Dr. Reddy’s logo and NDC number are printed on the outside of the package. The recalled medications include the following:
|
Recalled Prescription Drugs
|
NDC Numbers |
Carton Configurations |
Lot Numbers |
Expiration Dates |
|
Imatinib Mesylate Tablets 100 mg |
43598-344-31
|
3 blister cards of 10 tablets
|
H2000138
|
2022-0630 |
|
Imatinib Mesylate Tablets 400 mg |
43598-345-31 |
3 blister cards of 10 tablets |
H2000127 |
2022-0630 |
|
Pregabalin Capsules 50 mg |
43598-292-66 |
5 blister cards of 10 capsules |
T900876 |
2021-0630 |
|
Pregabalin Capsules 75 mg |
43598-293-66 |
5 blister cards of 10 capsules |
T901021 |
2021-0731 |
|
Pregabalin Capsules 100 mg |
43598-294-66 |
5 blister cards of 10 capsules |
T901022 |
2021-0731 |
|
Pregabalin Capsules 150 mg |
43598-295-66 |
5 blister cards of 10 capsules |
T901023 |
2021-0731 |
|
Sevelamer Carbonate Tablets 800 mg |
55111-789-11 |
4 blister cards of 25 tablets |
T801003, T000009, T900221 |
2020-1031, 2021-1231, 2021-0228 |
|
Tadalafil Tablets 5 mg |
43598-575-31 |
3 blister cards of 10 tablets |
T000376 |
2022-0131 |
|
Tadalafil Tablets 20 mg |
43598-573-31 |
3 blister cards of 10 tablets |
T000425 |
2022-0228 |
Consumers should immediately store the recalled medications in a safe location out of reach of children and contact Dr. Reddy’s for a full refund.
No incidents or injuries have been reported.
Dr. Reddy’s Laboratories, Inc., of Princeton, N.J.
Note: Individual Commissioners may have statements related to this topic. Please visit www.cpsc.gov/commissioners to search for statements related to this or other topics.
Related Recalls
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The outer packaging meant to prevent access to the contents can split open near the zipper track, posing a risk of serious injury to children and other vulnerable populations if the contents of the laundry detergent packets are ingested, as well as posing a risk of skin or eye injuries. Ingestion of a large quantity of any surfactant-containing household cleaning products can cause death among individuals with underlying health issues.
The portable fuel containers violate the child-resistant requirements for closures under the Children's Gasoline Burn Prevention Act (CGBPA). The closure for the products is not child resistant, posing a risk of burns and poisoning to children.
Compressed helium from the tank can escape and cause the plastic cap to be released into the air unexpectedly, posing an injury hazard due to projectiles striking users and bystanders.
The candy’s rolling ball can detach from the product’s container into a child’s mouth, posing a choking hazard for consumers.
The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury or death associated with the use of thousands of types of consumer products. Deaths, injuries, and property damage from consumer product-related incidents cost the nation more than $1 trillion annually. CPSC's work to ensure the safety of consumer products has contributed to a decline in the rate of injuries associated with consumer products over the past 50 years.
Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC.
- Visit CPSC.gov.
- Sign up to receive our email alerts.
- Follow us on Facebook, Instagram @USCPSC and Twitter @USCPSC.
- Report a dangerous product or product-related injury on www.SaferProducts.gov.
- Call CPSC’s Hotline at 800-638-2772 (TTY 800-638-8270).
- Contact a media specialist.
