KVK-Tech Recalls Hydrocodone and Homatropine Tablets for Impurity Failures
KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets, USP, 5 mg/1.5 mg, 30-count bottles. The recall is due to the product failing impurities and degradation specifications.
The affected product is identified by Lot 15684A with an expiration date of 7/2021. The NDC number is 10702-055-03. The product was distributed nationwide in the USA.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
- Brand
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,096
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 (2)
- Lot: 15684A
- Exp 7/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- ModerateKVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles
FDA (Drugs) · 2019-11-20
- ModerateNovel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
FDA (Drugs) · 2018-03-21
Same manufacturer · KVK-Tech, Inc.
See all →- ModeratePhentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateIndomethacin Extended-Release Capsules Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-28
- SevereBetaxolol Hydrochloride tablets recalled due to oxycodone contamination
FDA (Drugs) · 2023-10-25
- SevereAtovaquone Oral Suspension Recalled for Temperature Abuse
FDA (Drugs) · 2021-09-01
- LowKVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity
FDA (Drugs) · 2021-01-20
Same hazard · impurities
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateKVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles
FDA (Drugs) · 2019-11-20
- ModerateNovel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
FDA (Drugs) · 2018-03-21
- LowKVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity
FDA (Drugs) · 2021-01-20
- LowKVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures
FDA (Drugs) · 2017-08-23
- SevereBetaxolol Hydrochloride tablets recalled due to oxycodone contamination
FDA (Drugs) · 2023-10-25
- ModerateKVK-Tech Recalls Hydroxyzine Hydrochloride Tablets Due to Unapproved Ingredient Source
FDA (Drugs) · 2014-01-29