CLASS II Drug recall · Reported 29 Mar 2017 · FDA Enforcement Report
Famciclovir tablets, 500 mg recalled by AVKARE
Avkare is recalling Famciclovir tablets, 500 mg, distributed nationwide in the US. The recall was initiated on 15 Feb 2017 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-0610-2017
- FDA event ID
- 76617
- Recalling firm
- Avkare, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2017
- FDA classified
- 22 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Feb 2017 | Recall initiated by company | |
| 22 Mar 2017 | Classified by FDA | +35 days |
| 29 Mar 2017 | Published in enforcement report | +7 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: Product was above specification for unknown impurities.
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
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Which lots are affected?
Lot #15152, Exp. 02/2018
Where was it sold?
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 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 Avkare
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|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
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| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Famciclovir recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Famciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovir | Macleods Pharmaceuticals | Packaging Defects | Nationwide |
| 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, Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |