CLASS II Drug recall · Reported 27 Jan 2021 · FDA Enforcement Report
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) recalled
American Health Packaging is recalling Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton x 10, distributed nationwide in the US. The recall was initiated on 7 Jan 2021 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-0232-2021
- FDA event ID
- 87154
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2021
- FDA classified
- 15 Jan 2021
- Reported
- 27 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 7 Jan 2021 | Recall initiated by company | |
| 15 Jan 2021 | Classified by FDA | +8 days |
| 27 Jan 2021 | 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 (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # 193757, Exp 1/31/2022
Where was it sold?
Nationwide USA
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 American Health Packaging
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|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Nitrofurantoin (monohydrate recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalledNitrofurantoin (monohydrate/macrocrystals) | Sandoz | Packaging Defects | Nationwide |