Verna, N/A, India
Micro Labs Limited recalls
3 recalls recorded since 2018, most recently on 22 July 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 22 July 2026
- Reason
- Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0730-2026
- Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.
Ongoing Class II Drugs
- Recall started
- 12 February 2024
- Reason
- CGMP Deviations: Out of specification for residual solvents.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0348-2024
- Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
Terminated Class II Drugs
- Recall started
- 9 February 2024
- Terminated
- 24 June 2025
- Reason
- Failed Stability Specifications: Out of specification for blend uniformity.
- Distribution
- Puerto Rico, TN, RI
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0388-2024
- Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.