Recall Register

Food, drugs, devices › Firms

Macleods Pharmaceuticals Ltd

FDA recalling firm · 3 enforcement events · 3 product records · 2024–2025 · N/A

Macleods Pharmaceuticals Ltd has 3 FDA enforcement events on this register (3 product records) between 2024 and 2025: 3 drug; the busiest year was 2025 with 2.

0% of its events are Class I; the most common class is Class III (2). 3 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
11 Jun 2025Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.DrugClass III1Ongoing
29 May 2025Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.DrugClass III1Ongoing
25 Nov 2024Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.DrugClass II1Ongoing

By type and class

Drug3
Class III2
Class II1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

24
25
26
Enforcement events for Macleods Pharmaceuticals Ltd by year initiated.

Questions and answers

How many FDA recalls has Macleods Pharmaceuticals Ltd had?

3 enforcement events (3 product records) on this register, 2024–2025: 3 drug.

Are any Macleods Pharmaceuticals Ltd recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Macleods Pharmaceuticals Ltd recalls?

2 Class III, 1 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.