American Health Packaging Recalls Doxycycline Hyclate Tablets for Dissolution Failure
American Health Packaging is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications at the end of their shelf life.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which affects drug efficacy but does not involve acute toxicity or immediate serious injury.
Plain-English summary
American Health Packaging is recalling 15,755 cartons of Doxycycline Hyclate Tablets, USP, 100 mg. The affected product is distributed nationwide in the United States and is identified by NDC 62584-693-21 (carton) and 62584-693-11 (unit dose). The recall involves specific lots with expiration dates ranging from June 2020 to January 2021.
The recall was initiated because the tablets failed to meet the required dissolution specifications. Specifically, dissolution results were 59% at the 24-month time point, which is below the required minimum of 85% at the end of the shelf life. This failure means the medication may not dissolve properly in the body, potentially affecting its therapeutic effectiveness.
Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or physician for a replacement. The recalled product is a prescription-only medication, so patients should consult their healthcare provider regarding alternative treatments or replacements.
The recalled product
- Product
- DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE HYCLATE
- Manufacturer
- American Health Packaging
- Category
- Drug — Antibiotic
- Affected units
- 15,755
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 (6)
- Lots 179605
- Exp 06/30/2020
- 181105
- Exp 08/31/2020
- 183019
- Exp 01/31/2021
Distribution
Distributed nationwide across the United States.
Related recalls
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FDA (Drugs) · 2020-06-10
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Similar recalls
- ModerateAmerican Health Packaging Recalls Doxycycline Hyclate Tablets for Dissolution Failure
FDA (Drugs) · 2019-08-07
- ModerateMajor Pharmaceuticals Recalls Doxycycline Hyclate Tablets for Dissolution Failures
FDA (Drugs) · 2018-08-08
- ModerateWest-Ward Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure
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- ModerateWest-Ward Recalls Doxycycline Hyclate Tablets for Dissolution Failures
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