The Recall Desk
HighCPSC·21089·Announced 2021-02-25

Dr. Reddy's Recalls Prescription Blister Packages Due to Poisoning Risk

Dr. Reddy's is recalling prescription blister packages because the packaging is not child-resistant, posing a poisoning risk to young children.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (poisoning from non-child-resistant packaging) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Dr. Reddy's Laboratories is recalling approximately 21,400 units of prescription medications in blister packages. The affected products include Imatinib Mesylate Tablets (100 mg and 400 mg), Pregabalin Capsules (50 mg, 75 mg, 100 mg, and 150 mg), Sevelamer Carbonate Tablets (800 mg), and Tadalafil Tablets (5 mg and 20 mg). These medications were labeled and distributed by Dr. Reddy's for institutional use only but were distributed by third-party wholesalers to retail pharmacies, where they could have been dispensed to consumers.

The recall is due to a risk of poisoning. The packaging of the recalled products is not child-resistant, which can pose a risk if the contents are swallowed by young children. No incidents or injuries have been reported.

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. Dr. Reddy's can be reached toll-free at 888-375-3784 from 8 a.m. to 8 p.m. ET Monday through Friday, or online at www.drreddys.com by clicking on "Recall". Consumers should report incidents related to children accessing or ingesting these prescription medications to www.SaferProducts.gov.

The recalled product

Product
Imatinib Mesylate Tablets 100 mg, Imatinib Mesylate Tablets 400 mg, Pregabalin Capsules 50 mg, Pregabalin Capsules 75 mg, Pregabalin Capsules 100 mg, Pregabalin Capsules 150 mg, Sevelamer Carbonate Tablets 800 mg, Tadalafil Tablets 5 mg and Tadalafil Tablets 20 mg
Manufacturer
Dr. Reddy's Laboratories, Ltd., of India
Category
Drug — Prescription Medications
Hazard
Affected units
21,400

Distribution

Distributed nationwide across the United States.

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