CLASS III Drug recall · Reported 13 Apr 2016 · FDA Enforcement Report
Minocycline Hydrochloride Capsules USP, 100 mg* Dose blisters recalled
Apace KY is recalling Minocycline Hydrochloride Capsules USP, 100 mg* Dose blisters (, distributed nationwide in the US. The recall was initiated on 12 Feb 2016 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-0811-2016
- FDA event ID
- 73326
- Recalling firm
- Apace KY, Fountain Run, KY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Feb 2016
- FDA classified
- 5 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
Timeline
| 12 Feb 2016 | Recall initiated by company | |
| 5 Apr 2016 | Classified by FDA | +53 days |
| 13 Apr 2016 | Published in enforcement report | +8 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: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Product as listed by the FDA
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.
Where it was distributed
All product was shipped to KY and further distributed Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017
Where was it sold?
All product was shipped to KY and further distributed 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 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.
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| Drug | CLASS II | Amantadine HCl Capsules, USP, 100 mg recalled by Apace KY | Apace KY | Other | KY |
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Other Minocycline recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg recalledMinocycline Hydrochloride | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg* recalledMinocycline Hydrochloride | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Minocycline HCL, Capsule, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Minocycline HCL, Capsule, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |