CLASS III ONGOING Drug recall · Reported 16 Jul 2025 · FDA Enforcement Report
Famciclovir Tablets, USP 500 mg recalled by Macleods Pharmaceuticals
Macleods Pharmaceuticals is recalling Famciclovir Tablets, USP 500 mg, distributed nationwide in the US. The recall was initiated on 11 Jun 2025 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-0509-2025
- FDA event ID
- 97058
- Recalling firm
- Macleods Pharmaceuticals, Mumbai, N/A
- Brand
- Famciclovir
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 11 Jun 2025
- FDA classified
- 7 Jul 2025
- Reported
- 16 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 11 Jun 2025 | Recall initiated by company | |
| 7 Jul 2025 | Classified by FDA | +26 days |
| 16 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Famciclovir 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.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Is Famciclovir Tablets, USP 500 mg recalled?
Yes. Macleods Pharmaceuticals recalled Famciclovir Tablets, USP 500 mg on 11 Jun 2025. The recall is Class III and its status is Ongoing. Recall number D-0509-2025.
Why was it recalled?
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Which lots are affected?
Lot # 12250247B, Exp. 01/31/2027
Where was it sold?
U.S. Nationwide.
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.
More recalls from Macleods Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Levothyroxine Sodium Tablets, USP 112 mcg 112mg) recalledLevothyroxine Sodium | Macleods Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
Other Famciclovir recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Famciclovir Tablets, 500 mg recalled by Hetero Labs Limited Unit VFamciclovir | Hetero Labs Limited Unit V | Temperature Abuse | Nationwide |
| Drug | CLASS II | Famciclovir tablets, 500 mg recalled by AVKARE | AVKARE | Potency & Assay | Nationwide |