CLASS III Drug recall · Reported 5 Dec 2018 · FDA Enforcement Report
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg recalled
RemedyRepack is recalling Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, distributed in Pennsylvania. The recall was initiated on 7 Nov 2018 and the FDA has classified it as Class III.
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-0284-2019
- FDA event ID
- 81638
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Nov 2018
- FDA classified
- 27 Nov 2018
- Reported
- 5 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Antibiotics
Timeline
| 7 Nov 2018 | Recall initiated by company | |
| 27 Nov 2018 | Classified by FDA | +20 days |
| 5 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard trays & HDPE 60 cc bottles in plastic bags, Repackaged NDC 70518-1087-01, 10 capsules in HDPE 60 cc bottles in cardboard trays.
Where it was distributed
Product was distributed to two medical facilities in Pennsylvania.
Questions about this recall
Why was it recalled?
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Which lots are affected?
Lot #: B0484872-081718, B0481339-081018, Exp 08/2019; B0506246-092718, Exp 09/2019; B0509938-100418, Exp 10/2019
Where was it sold?
Product was distributed to two medical facilities in Pennsylvania.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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Other Nitrofurantoin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitrofurantoin Capsules, USP, 100 mg Dose recalled by AvKARE | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg recalledNitrofurantoin Monohydrate/ Macrocrystalline | Alvogen | Potency & Assay | PR |
| Drug | CLASS II | Macrobid Urinary Tract Anitbacterial, 100 mg recalled by AlvogenMacrobid | Alvogen | Potency & Assay | PR |
| Drug | CLASS II | Nitrofurantoin Oral Suspension, USP, 25mg recalled by Lupin SomersetNitrofurantoin | Lupin Somerset | Potency & Assay | Nationwide |