CLASS II Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report
Indomethacin Capsules, USP, 50 mg recalled
Hetero Labs Ltd. - Unit III is recalling Indomethacin Capsules, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 18 Jul 2018 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-1019-2018
- FDA event ID
- 80589
- Recalling firm
- Hetero Labs Ltd. - Unit III, Hyderabad, N/A
- Brand
- Indomethacin
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2018
- FDA classified
- 27 Jul 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 18 Jul 2018 | Recall initiated by company | |
| 27 Jul 2018 | Classified by FDA | +9 days |
| 8 Aug 2018 | Published in enforcement report | +12 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 Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Product as listed by the FDA
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Which lots are affected?
Lot #: E180315, Exp 12/19
Where was it sold?
Nationwide in the 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 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 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 Hetero Labs Ltd. - Unit III
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibrate Tablets, USP 145 mg recalled by Hetero Labs, Ltd. - Unit IIIFenofibrate | Hetero Labs Ltd. - Unit III | Other | IN, LA |
| Drug | CLASS II | Aripiprazole Tablets, USP, 10 mg recalledAripiprazole | Hetero Labs Ltd. - Unit III | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Simvastatin Tablets, USP, 40 mg recalled by Hetero Labs, Ltd. - Unit IIISimvastatin | Hetero Labs Ltd. - Unit III | Other | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution, USP, 100 mg/mL recalledLevetiracetam | Hetero Labs Ltd. - Unit III | Packaging Defects | NJ |
Other Indomethacin recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules, 75mg recalledIndomethacin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Indomethacin 25mg Capsules recalled by Glenmark PharmaceuticalsIndomethacin | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |