CLASS II Drug recall · Reported 24 Jul 2024 · FDA Enforcement Report
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg recalled
SUN Pharmaceutical Industries is recalling Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, distributed nationwide in the US. The recall was initiated on 9 Jul 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0597-2024
- FDA event ID
- 94950
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Nitrofurantion
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2024
- FDA classified
- 12 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 9 Jul 2024 | Recall initiated by company | |
| 12 Jul 2024 | Classified by FDA | +3 days |
| 24 Jul 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #s: 231067, 231069, Exp 04/30/2025
Where was it sold?
Nationwide in the USA and Puerto rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SUN Pharmaceutical Industries
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |