Lamivudine Oral Solution — Class III drug recall D-1416-2015
Terminated recall by Silarx Pharmaceutical, Inc., reported 2015-09-09, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration d
| Recall number | D-1416-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Silarx Pharmaceutical, Inc., Carmel, NY, United States |
| Recall initiated | 2015-08-21 |
| Classified | 2015-09-03 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2015-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 576 bottles |
| Reason classes | labeling |
| NDC | 54838-0566-70 |
| Lot numbers | 05/18, 0649A |
Product
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
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1416-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.