CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report
Finasteride Tablets USP, 1 mg recalled by Accord Healthcare
Accord Healthcare is recalling Finasteride Tablets USP, 1 mg, distributed in Puerto Rico. The recall was initiated on 7 Feb 2023 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-0390-2023
- FDA event ID
- 91657
- Recalling firm
- Accord Healthcare, Durham, NC
- Brand
- Finasteride
- Manufacturer
- Accord Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2023
- FDA classified
- 2 Mar 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Bladder & Prostate Medication
Timeline
| 7 Feb 2023 | Recall initiated by company | |
| 2 Mar 2023 | Classified by FDA | +23 days |
| 8 Mar 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Product as listed by the FDA
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Where it was distributed
United States including Puerto Rico and Canada
Questions about this recall
Is Finasteride Tablets USP, 1 mg recalled?
Yes. Accord Healthcare recalled Finasteride Tablets USP, 1 mg on 7 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0390-2023.
Why was it recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
Which lots are affected?
Batches: a) P2005979, Exp. Date 10/31/2023; P2100252, Exp. Date 12/31/2023; P2101710, Exp. Date 2/29/2024; b) P2100253, Exp. Date 12/31/2023; P2103035, Exp. Date 4/30/2024; P2103036, Exp. Date 4/30/2024;
Where was it sold?
United States including Puerto Rico and Canada
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 21 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 Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg 112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg 088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg 1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg 175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
Other Finasteride recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Finasteride Tablets, USP, 5 mg recalled by Preferred Pharmaceuticals | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Finasteride Tablets USP, 5 mg recalled by Accord HealthcareFinasteride | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Finasteride Tablets USP 1 mg, Keeps recalled by Accord Healthcare | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS III | Finasteride Tablets, USP 5 mg recalled by Hetero Drugs Ltd. - Unit 1Finasteride | Hetero Drugs Ltd. - Unit 1 | Other | NJ |
| Drug | CLASS II | Finasteride Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |