Nostrum Laboratories Inc FDA Record
Nostrum Laboratories Inc has 8 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nostrum Laboratories Inc" is on file.
- Latest recall
- D-0547-2025 · Class II · Jul 11, 2025
- Latest inspection
- Mar 13, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 8 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 1 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 2 | 0 |
| 2020 | 0 | 0 | 0 | 3 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 1 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0547-2025 | Class II | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count… | Jul 11, 2025 |
| D-0249-2021 | Class II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only… | Jan 25, 2021 |
| D-0227-2021 | Class II | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only… | Jan 4, 2021 |
| D-0068-2021 | Class II | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only… | Oct 23, 2020 |
| D-0067-2021 | Class II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only… | Oct 23, 2020 |
| D-1059-2020 | Class II | Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured… | Mar 6, 2020 |
| D-0473-2018 | Class III | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum… | Feb 13, 2018 |
| D-1030-2016 | Class II | Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx… | May 23, 2016 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 13, 2025 | Bryan, OH | Drugs | Voluntary Action Indicated (VAI) | 1518957 |
| Jan 11, 2018 | Bryan, OH | Drugs | No Action Indicated (NAI) | 1518957 |
| Mar 15, 2016 | Bryan, OH | Drugs | No Action Indicated (NAI) | 1518957 |
| Jun 28, 2013 | Bryan, OH | Drugs | Voluntary Action Indicated (VAI) | 1518957 |
| Jul 21, 2011 | Bryan, OH | Drugs | Voluntary Action Indicated (VAI) | 1518957 |
| Jul 16, 2010 | Bryan, OH | Drugs | Voluntary Action Indicated (VAI) | 1518957 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1518957 | Bryan, OH | 6 | Mar 13, 2025 |
Nostrum Laboratories Inc and the FDA: common questions
Has Nostrum Laboratories Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Nostrum Laboratories Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Nostrum Laboratories Inc received an FDA Form 483?
FDA has not published a Form 483 for "Nostrum Laboratories Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nostrum Laboratories Inc?
The most recent FDA inspection on file ended Mar 13, 2025 at Bryan, OH and was classified VAI. FDA has 6 inspections of Nostrum Laboratories Inc on file.
Has Nostrum Laboratories Inc had an FDA recall?
Yes. Nostrum Laboratories Inc has 8 FDA recalls on record. The most recent started Jul 11, 2025.
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