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RAMIPRIL Recall D-0054-2025

Description: Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India

RAMIPRIL Recall D-0054-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0054-2025
Event ID95610
BrandRAMIPRIL
Generic NameRAMIPRIL
ManufacturerRAMIPRIL
Original Package?1
Active SubstanceRAMIPRIL
Drug RouteORAL
DistributionProduct was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Quantity357,414 bottles
Recall ReasonCGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Drug ClassificationClass II
Drug Code Info20241127
Product NDC68180-588 68180-589 68180-590
Product NUIN0000175562 N0000000181
Drug UPC0368180589099 0368180590095 0368180591092
Pharma Class (EPC)Angiotensin Converting Enzyme Inhibitor [EPC]
Recall Initiation Date20241023
Report Date20241127
Classification Date20241119
AddressHarborplace Tower111 S Calvert St Fl 21st
Baltimore, MD 21202-6174
United States
Recalling FirmLupin Pharmaceuticals Inc.
Initial Notification Letter
Unique Ingredient IdentifierL35JN3I7SJ
Drug Application NumberANDA077626
Structured Product Labeling (SPL ID)25692bd2-4add-49c4-adad-baed736213c6
Structured Product Labeling (SPL Set ID)a8cdec12-81d1-4ef4-82c0-d05d93c37a07
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