Prescription Drug Recall: Ramipril Capsules from Unapproved Supplier
Lupin Pharmaceuticals is recalling certain lots of Ramipril 5 mg capsules because the active ingredient was sourced from an unapproved vendor, raising concerns about product quality and safety.
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 for a manufacturing deviation involving an unapproved supplier of the active pharmaceutical ingredient. Per the rubric, Class II recalls involving potential quality and safety risks without reported hospitalizations classify as High severity (Score 3).
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling certain batches of Ramipril Capsules USP 5 mg due to a manufacturing deviation. The active pharmaceutical ingredient was sourced from a vendor not approved by the FDA. This recall affects 146,322 bottles that were distributed to 30 wholesalers and distributors nationwide.
The recalled product includes Ramipril Capsules 5 mg in three package sizes with NDC numbers 68180-590-09, 68180-590-01, and 68180-590-02. Specific lot numbers and expiration dates for affected products are listed in the FDA recall notice. Consumers should check their medication bottle to determine if their product is included.
The FDA classified this recall as Class II. The manufacturing deviation involves the active pharmaceutical ingredient being sourced from an unapproved supplier, raising concerns about product quality and safety.
If you have one of the affected lots, contact your pharmacist or healthcare provider. Your pharmacy has been notified and should have instructions for returning or replacing the affected product.
The recalled product
- Product
- RAMIPRIL (RAMIPRIL)
- Brand
- RAMIPRIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Affected units
- 146,322
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 (13)
- a) NDC 68180-590-09
- Lots G326928
- exp. date 30-Sep-25
- GA00964
- exp. date 31-Dec-25
- b) NDC 68180-590-01
- Lots G326897
- G326929
- GA00854
- GA00933
- GA00954
- c) NDC 68180-590-02
- Lot GA00955
UPCs (3)
- 0368180591092
- 0368180589099
- 0368180590095
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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