CLASS III Drug recall · Reported 25 May 2022 · FDA Enforcement Report
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled
American Health Packaging is recalling Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (10 x blisters per card, distributed nationwide in the US. The recall was initiated on 3 May 2022 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-0880-2022
- FDA event ID
- 90191
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 May 2022
- FDA classified
- 18 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 3 May 2022 | Recall initiated by company | |
| 18 May 2022 | Classified by FDA | +15 days |
| 25 May 2022 | Published in enforcement report | +7 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: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
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 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Which lots are affected?
Lot # 1003829, Exp date 1/31/23
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 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.
More recalls from American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | 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 |
| Drug | CLASS II | GlipiZIDE Extended-Release Tablets, 2.5 mg recalled | American Health Packaging | Potency & Assay | Nationwide |
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 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 |
| Drug | CLASS III | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg recalled | RemedyRepack | Foreign Material | PA |