Minocycline Hydrochloride Capsules USP — Class III drug recall D-0811-2016
Terminated recall by Apace KY LLC, reported 2016-04-13, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect l
| Recall number | D-0811-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apace KY LLC, Fountain Run, KY, United States |
| Recall initiated | 2016-02-12 |
| Classified | 2016-04-05 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 291 cartons |
| Reason classes | labeling |
| NDC | 50268-0569-11, 50268-0569-13 |
| Lot numbers | 13560, 13650 |
| Expiration dates | 2017-06 |
Product
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
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-0811-2016. 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.