Methylphenidate Hydrochloride Tablets Recalled Due to Metal Contamination
Sun Pharmaceutical Industries is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets (20mg) due to metal embedded in some tablets. No illnesses have been reported.
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: This is an FDA Class II recall with a physical contamination hazard (metal embedded in tablets). Although no illnesses or injuries have been reported, the presence of metal in tablets represents a risk-of-harm product meeting the criteria for Score 3.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets, USP 20mg (Lot AC74459, expiration 07/31/2024). The tablets are manufactured by Ohm Laboratories Inc., New Brunswick, NJ, and distributed by Sun Pharmaceutical Industries Inc., Cranbury, NJ.
The recall was initiated due to the presence of metal embedded in some tablets. The product was distributed nationwide.
Patients currently taking this medication should not use tablets from the recalled lot and should consult their healthcare provider. The affected package NDC numbers include 57664-228, 57664-229, and 57664-230.
The recalled product
- Product
- METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
- Brand
- METHYLPHENIDATE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- metal-contamination
- foreign-object
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot AC74459
- Exp 07/31/2024
UPCs (3)
- 0357664228883
- 0357664229880
- 0357664230886
Distribution
Distributed nationwide across the United States.
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