Avet Pharmaceuticals Recalls Tetracycline Hydrochloride Capsules for Dissolution Failure
Avet Pharmaceuticals is recalling Tetracycline Hydrochloride capsules due to out-of-specification dissolution results found during long-term testing.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Avet Pharmaceuticals, Inc. is recalling Tetracycline Hydrochloride Capsules, USP, 250 mg, 100-count bottles. The recall affects 4,444 bottles of the product, which is distributed nationwide in the US. The specific lot number is H190666, with an expiration date of July 2022.
The recall was initiated because the product failed dissolution specifications. Specifically, an out-of-specification result was identified during long-term testing of the Tetracycline HCl capsules. This indicates that the medication may not dissolve at the required rate, potentially affecting its efficacy.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The product is a prescription-only medication manufactured for Heritage Pharmaceuticals Inc.
The recalled product
- Product
- TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE HYDROCHLORIDE)
- Brand
- TETRACYCLINE HYDROCHLORIDE
- Manufacturer
- Avet Pharmaceuticals, Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 4,444
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 # H190666
- Exp JUL 2022
UPCs (1)
- 0323155017014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Avet Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · TETRACYCLINE HYDROCHLORIDE
- SevereAvet Pharmaceuticals Recalls Tetracycline Hydrochloride Capsules for Dissolution Failures
FDA (Drugs) · 2020-04-15
Same manufacturer · Avet Pharmaceuticals, Inc.
See all →- SevereAvet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
FDA (Drugs) · 2020-04-15
- SevereAvet Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
FDA (Drugs) · 2020-04-15
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateTeva Recalls Methylphenidate Hydrochloride Capsules Due to Dissolution Failures
FDA (Drugs) · 2013-08-14
- ModerateTeva Recalls Methylphenidate Hydrochloride Capsules for Dissolution Failures
FDA (Drugs) · 2013-08-14
- ModerateTeva Recalls Methylphenidate Hydrochloride Extended-Release Capsules Due to Dissolution Failure
FDA (Drugs) · 2013-08-14
- ModerateZydus Recalls Venlafaxine Hydrochloride Capsules for Dissolution Failures
FDA (Drugs) · 2016-08-24
- ModerateTeva Recalls Dutasteride and Tamsulosin HCl Capsules for Dissolution Failures
FDA (Drugs) · 2017-11-08
- ModerateAscend Recalls Tamsulosin Hydrochloride Capsules Due to Dissolution Failure
FDA (Drugs) · 2019-03-13