CLASS III Drug recall · Reported 9 Sep 2015 · FDA Enforcement Report
Lamivudine Oral Solution, USP, 10 mg recalled by Silarx Pharmaceutical
Silarx Pharmaceutical is recalling Lamivudine Oral Solution, USP, 10 mg per, distributed nationwide in the US. The recall was initiated on 21 Aug 2015 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-1416-2015
- FDA event ID
- 71952
- Recalling firm
- Silarx Pharmaceutical, Carmel, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Aug 2015
- FDA classified
- 3 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 21 Aug 2015 | Recall initiated by company | |
| 3 Sep 2015 | Classified by FDA | +13 days |
| 9 Sep 2015 | 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
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Product as listed by the FDA
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
Where it was distributed
Nationwide
Questions about this recall
Is Lamivudine Oral Solution, USP, 10 mg per recalled?
Yes. Silarx Pharmaceutical recalled Lamivudine Oral Solution, USP, 10 mg per on 21 Aug 2015. The recall is Class III and its status is Terminated. Recall number D-1416-2015.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Which lots are affected?
Lot # 0649A Exp. Date 05/18 (unit carton)
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 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.
Other Lamivudine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lamivudine Tablets, USP, 150 mg Unit Dose Blisters recalled | American Health Packaging | Packaging Defects | Nationwide |