CLASS III ONGOING Drug recall · Reported 23 Aug 2023 · FDA Enforcement Report
Tobramycin Opthalmic Solution recalled by Alembic Pharmaceuticals
Alembic Pharmaceuticals is recalling Tobramycin Opthalmic Solution USP, 0.3%, distributed nationwide in the US. The recall was initiated on 27 Jul 2023 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-1086-2023
- FDA event ID
- 92811
- Recalling firm
- Alembic Pharmaceuticals, Bedminster, NJ
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 27 Jul 2023
- FDA classified
- 17 Aug 2023
- Reported
- 23 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 27 Jul 2023 | Recall initiated by company | |
| 17 Aug 2023 | Classified by FDA | +21 days |
| 23 Aug 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
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
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 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 Alembic Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg recalledFesoterodine Fumarate | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxepin Hydrochloride Capsules, USP, 10 mg recalledDoxepin Hydrochloride | Alembic Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Celecoxib Capsules, 200 mg recalled by Alembic PharmaceuticalsCelecoxib | Alembic Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | Bromfenac Ophthalmic Solution recalled by Alembic PharmaceuticalsBromfenac Ophthalmic Solution 0.09% | Alembic Pharmaceuticals | Potency & Assay | Nationwide |
Other Tobramycin recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tobramycin for Injection, USP per Pharmacy recalled by Eugia USTobramycin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Tobramycin Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tobramycin Inhalation Solution USP, 300 mg/-dose ampules recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Tobramycin 660MG IN NS, antibiotic recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Tobramycin Ophthalmic Solution, USP, 0.3% per dropper recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |