Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported April 13, 2016
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.
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.
Apace Ky LLC recalled Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters … - a low-severity action.
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters … was recalled by Apace Ky LLC in April 13, 2016. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect …. Check the official notice for the remedy. Verify recall #D-0811-2016 with the FDA Drug before acting.
The recall
Apace Ky LLC issued this low-severity FDA Drug recall-Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect ….
- Low
- severity level
- Class III
- classification
- April 13, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0811-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0811-2016) was formally reported on April 13, 2016, with the manufacturer initiating the action on February 12, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Apace Ky LLC is listed as the recalling firm, operating out of Fountain Run, KY. Federal records list the affected scope as 291 cartons.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: All product was shipped to KY and further distributed Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
291 cartons
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0811-2016 |
| Date reported | April 13, 2016 |
| Date initiated | February 12, 2016 |
| Recalling firm | Apace Ky LLC |
| Firm location | Fountain Run, KY |
| Affected scope | 291 cartons |
| Distribution | All product was shipped to KY and further distributed Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0811-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Apace Ky LLC. Units affected: 291 cartons.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2016. Severity: Low. Recall number: D-0811-2016.
Where was the recalled product distributed? ▼
Distribution: All product was shipped to KY and further distributed Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0811-2016) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 13, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.