Major Pharmaceuticals Recalls Doxycycline Hyclate Tablets for Dissolution Failures
Major Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications.
What this means for you
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 due to a quality control failure (dissolution) that may affect drug efficacy but is not associated with reported serious injuries or deaths, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling 3,161 cartons of Doxycycline Hyclate Tablets, USP, 100 mg. The specific lot affected is 71545AA, with an expiration date of 7/2019. The product is distributed nationwide in the United States.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases at the appropriate rate in the body. If the tablets do not dissolve correctly, the medication may not be absorbed as intended, potentially affecting its therapeutic efficacy.
Consumers and healthcare providers should stop using the affected lot and return it to the pharmacy or point of purchase. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE HYCLATE
- Manufacturer
- MAJOR PHARMACEUTICALS
- Category
- Drug — Antibiotic
- Affected units
- 3,161
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: 71545AA
- exp 7/2019
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2019-08-07
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