Sun Pharmaceutical Recalls Doxycycline Capsules Due to Manufacturing Deviations
Sun Pharmaceutical Industries is recalling 624 bottles of Doxycycline Capsules, 75 mg, because they were not manufactured under Current Good Manufacturing Practice conditions.
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. The source text does not report any illnesses, injuries, or specific contamination, indicating a theoretical risk associated with manufacturing deviations rather than a confirmed high-risk pathogen or injury event.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 624 bottles of Doxycycline Capsules, USP, 75 mg, 100-count bottles. The product is prescription-only and was distributed nationwide in the USA. The specific lot number is AA39490 with an expiration date of 03/2021.
The recall was initiated because the doxycycline capsules were not manufactured under Current Good Manufacturing Practice (CGMP) conditions. The capsules were manufactured by Ohm Laboratories Inc. in New Brunswick, NJ, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. The recall is classified as Class II by the FDA.
The recalled product
- Product
- DOXYCYCLINE (DOXYCYCLINE)
- Brand
- DOXYCYCLINE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Antibiotic
- Hazard
- Affected units
- 624
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 #: AA39490
- Exp 03/2021
UPCs (1)
- 0363304614015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sun Pharmaceutical Industries, 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.
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