CLASS III Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report
Finasteride Tablets, USP 5 mg recalled by Hetero Drugs Ltd. - Unit 1
Hetero Drugs Ltd. - Unit 1 is recalling Finasteride Tablets, USP 5 mg, distributed in New Jersey. The recall was initiated on 29 Dec 2016 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-0453-2017
- FDA event ID
- 76120
- Recalling firm
- Hetero Drugs Ltd. - Unit 1, Medak District, N/A
- Brand
- Finasteride
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Dec 2016
- FDA classified
- 31 Jan 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Bladder & Prostate Medication
Timeline
| 29 Dec 2016 | Recall initiated by company | |
| 31 Jan 2017 | Classified by FDA | +33 days |
| 8 Feb 2017 | 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
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Product as listed by the FDA
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Where it was distributed
NJ only.
Questions about this recall
Is Finasteride Tablets, USP 5 mg recalled?
Yes. Hetero Drugs Ltd. - Unit 1 recalled Finasteride Tablets, USP 5 mg on 29 Dec 2016. The recall is Class III and its status is Terminated. Recall number D-0453-2017.
Why was it recalled?
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Which lots are affected?
Lot #: FIN16002, Exp. 03/2018
Where was it sold?
NJ only.
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 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.
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, 1 mg recalled by Accord HealthcareFinasteride | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| 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 II | Finasteride Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |