Nitrofurantoin Capsules recall
FDA recall D-0597-2024 · initiated Jul 9, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Nitrofurantoin Capsules in Jul 2024 — an FDA Class II recall (D-0597-2024) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5752 bottles
Details
- Product
- Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Puerto rico
- Initiated
- Jul 9, 2024
- FDA report date
- Jul 24, 2024
Frequently asked
- Was Nitrofurantoin Capsules recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Nitrofurantoin Capsules in Jul 2024 — an FDA Class II recall (D-0597-2024) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Nitrofurantoin Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0597-2024 was: Failed Dissolution Specifications
- Is a recalled Nitrofurantoin Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nitrofurantoin Capsules are affected?
- Distributed: Nationwide in the USA and Puerto rico. The recall covers these lots — Lot #s: 231067, 231069, Exp 04/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0597-2024.