Apace KY LLC Recalls Minocycline Capsules Due to Mislabeled Lot Numbers
Apace KY LLC is recalling 291 cartons of Minocycline Hydrochloride Capsules because individual blisters are mislabeled with an incorrect lot number.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The issue is a labeling error regarding lot numbers, which is a documentation issue.
Plain-English summary
Apace KY LLC is voluntarily recalling 291 cartons of Minocycline Hydrochloride Capsules USP, 100 mg, 30 Capsules (3 x 10) Unit Dose blisters. The product is manufactured for AvKARE, Inc. and is available by prescription only.
The recall was initiated because the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650. The outer cases and cartons are correctly labeled with Lot # 13650 and an expiration date of 06/2017. The blisters are labeled with Lot # 13560 and an expiration date of 06/2017.
All product was shipped to Kentucky and further distributed nationwide. Consumers and healthcare providers should check their inventory for this specific product and stop using it if the blister lot number is 13560.
The recalled product
- 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.
- Manufacturer
- Apace KY LLC
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 291
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Outer Cases and Cartons Lot #: 13650
- EXP 06/2017
- Blisters Lot #: 13560
Distribution
Related recalls
Same manufacturer · Apace KY LLC
See all →- SevereAcyclovir Tablets Recalled Due to Presence of Torsemide Tablets
FDA (Drugs) · 2018-03-07
- ModerateApace KY LLC Recalls Amantadine HCl Capsules Due to Labeling Error
FDA (Drugs) · 2017-08-09
- SevereCyclobenzaprine Tablets Recalled for Incorrect Amantadine Labeling
FDA (Drugs) · 2017-08-09
- LowApace Recalls Enalapril Maleate Tablets Due to Illegible Labeling
FDA (Drugs) · 2012-09-26
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02