CLASS III Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Ferrous Sulfate recalled by Aidarex Pharmaceuticals
Aidarex Pharmaceuticals is recalling Ferrous Sulfate, distributed in Florida. The recall was initiated on 10 Apr 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-0810-2018
- FDA event ID
- 79835
- Recalling firm
- Aidarex Pharmaceuticals, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Apr 2018
- FDA classified
- 15 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 10 Apr 2018 | Recall initiated by company | |
| 15 May 2018 | Classified by FDA | +35 days |
| 23 May 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
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00
Where it was distributed
Product was distributed to Florida
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
NDC 33261-0715-00 Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019
Where was it sold?
Product was distributed to Florida
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 Aidarex Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 2.5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate Tablets, USP, 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | FL |
| Drug | CLASS III | Phentermine, USP Capsules, 15 mg recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | CA, NV |