Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PROMETHAZINE HYDROCHLORIDE Tablets Recalled by Zydus Pharmaceuticals USA Inc Due to Presence of Foreign Tablets: Presence of atenolol 25...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals USA Inc directly.
Affected Products
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01
Quantity: 10,200 bottles
Why Was This Recalled?
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals USA Inc
Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report